Method of tensioning a suspended tissue mass

ABSTRACT

The surgical treatment of stress urinary incontinence is described. The methods include: 1) a technique of probe passage to avoid injuring the bladder and to provide a more accurate and reproducible capture of the pubocervical fascia lateral to the bladder neck and urethra, 2) anchor fixation of the suspending sutures to the pubic bone to decrease the risk of suture pull through from above and to decrease post-operative pain and 3) a simple and reproducible technique to set a limited tension of the suspending sutures. A description of these methods and results of procedures with some of these methods are included. Novel drill guides, suture passers, suture tensioners, and various related tools and devices for use in the surgical method are also discussed.

This application is a continuation of U.S. patent application Ser. No.08/243,503, filed May 16, 1994, now U.S. Pat. No. 5,582,188; which is adivisional of U.S. patent application Ser. No. 08/042,739, filed Apr. 5,1993, now U.S. Pat. No. 5,611,515; which is a continuation-in-part ofU.S. patent application Ser. No. 07/862,847, filed Apr. 3, 1992,abandoned; which was a continuation-in-part of U.S. patent applicationSer. No. 07/801,747, filed Dec. 3, 1991, now abandoned.

BACKGROUND OF THE INVENTION

The present invention relates to the treatment of stress urinaryincontinence "SUI," and, in particular, to improved methods and surgicaldevices for the surgical treatment of SUI in females. The devicesdisclosed herein are additionally useful in a wide variety of othersurgical procedures.

Genuine stress incontinence is the involuntary loss of urine due to asudden rise in intra-abdominal pressure. It has been estimated thatbetween 40% and 50% of young, healthy nulliparous women admit tooccasional mild stress incontinence; however, at least 80% of stressincontinence patients are in the perimenopausal age group and aremultiparous. Raz³ has suggested that the female urethral continencemechanism is dependent on the interaction of four urethral factor:urethral closing pressure, urethral length, urethrotrigonal anatomy, andurethral reception of intra-abdominal pressure.

The urethral closing pressure is predominantly a result of theinteraction of smooth and striated muscle sphincter activity, but thereis also some contribution by nonmuscular urethral factors such as thesubmucosal vascular plexus, the elastin and collagen content of theurethral tissues, and a sphincter like effect of the mucosa. There hasbeen considerable diversity of opinion regarding the anatomic structureand the innervation of the urethral sphincters, and a variety of viewshave been expressed in the literature.

Lapides and associates have stressed the importance of urethral lengthin the maintenance of continence in the female. However, although itcertainly interacts with other factors to contribute to continence, ashort urethra alone will not produce incontinence. Urethral lengthvaries considerably in normal women, and women with proven genuinestress urinary incontinence do not invariably have urethral shortening.

Urethrotrigonal anatomy, which can be demonstrated by lateralcystourethrography, should fulfill certain criteria. The bladder baseshould lie above the level of the inferior ramus of the symphysis, andwith straining should not descend more than 1.5 cm. There should be anormal urethrotrigonal alignment with an angle normally less than 100degrees, and the urethral axis should be approximately 35 degrees fromthe vertical. In the hypermobile situation loss of all of the normalanatomic features may occur, a radiologic finding that correlates withthe clinical finding of cystourethrocele. However, clinical experiencehas shown that the coexistence of cystourethrocele and incontinence doesnot predict that the incontinence is of a genuine stress variety.

The transmission of intra-abdominal pressure to the intra-abdominalportion of the proximal urethra is also reported to be important in themaintenance of continence. This is a passive phenomenon, and is theresult of the normal anatomic configuration just described. Wheneverthere is a rise in intra-abdominal pressure during such stresses ascoughing or straining, the pressure is transmitted not only to thebladder but also to the proximal urethra, with resultant increase in theclosing pressure, and prevention of leakage. If the urethral axis isaltered, rotational descent will drop the proximal urethra and bladderbase from its intra-abdominal location, and will obviously impair suchpressure transmission.

A wide variety of operations have been used to correct this condition,generally involving the principles of elevating the bladder neckanteriorly and/or elongating and narrowing the proximal urethra. Two ofthe most popular operations today for female stress incontinence are theMarshall-Marchetti-Krantz and Birch vesicourethropexies. TheMarshall-Marchetti-Krantz technique has at least an eighty-five percentsuccess rate, against which other operative success rates must bemeasured. Recently, the Pereyra operation and its modifications haveenjoyed some popularity, but less than basic techniques.

Notwithstanding the foregoing, however, there remains a need for animproved treatment for SUI. Preferably, the treatment is as noninvasiveas possible under the circumstances, and will eliminate or minimizehospitalization and the use of general anesthetics. In addition, thereremains a need for improved medical instrumentation such as drill guidesand suture passers for use in connection with SUI treatment and othermedical procedures.

SUMMARY OF THE INVENTION

There is provided in accordance with one aspect of the present inventiona drill guide for directing a drill bit at a selected site on a bone.The drill guide comprises a housing, and at least two chambers extendingaxially within the housing. Each of the chambers has an opening at thedistal end. A plunger is provided in each of the chambers, each plungeraxially movable from a first retracted position to a second extendedposition. A probe is mounted on the distal end of each of the plungers,and adapted for retraction within the open end of the chamber andextension outside of the open end of the chamber. In a simplifiedembodiment, each of two or more probes is axially movably disposedwithin the housing, without the use of a distinct plunger. A drill guidechannel extends axially through the housing, within a plane parallel tothe plane joining the axes of the first and second chambers, and inbetween the axes of the first and second chambers.

Preferably, one or both of the plungers is provided with a releasablelock for releasably retaining the plunger in the retracted position,thereby minimizing the likelihood of accidental needle sticks. Thepreferred probe comprises a hypodermic needle or a sharpened solid wire.In a two probe embodiment, the axes of the first and second probes areseparated by a distance within the range from about 5 mm to about 15 mm.Preferably, the axis of the drill guide channel is approximatelyequidistant from the axes of each of the probes.

In accordance with another aspect of the present invention, there isprovided an alternate embodiment of a drill guide for use in locatingdrill sites in a patient's body. The drill guide comprises a body, ahandle connected thereto, and one or more bores extending through saidbody. Each bore has an opening at a distal end. A probe is provided ineach bore, the probe being axially movable from a retracted to anextended position. A drill guide bore, which may also act as one of theprobe bores, extends axially through the body. A suture slot extendsfrom outside of the body to the drill guide bore along the length of thebody. Serrations are provided on the distal end of the body, aiding inmaintaining the opening of a drilled hole. In a two probe embodiment,the axes of the probes are separated by a distance of about 5 to 10 mm.Preferably, the probes of this embodiment are a unitary element, such asa wire or needle. Further, it is desired that the drill guide bore andany probe bores lie in a line perpendicular to the longitudinal axis ofthe body.

In accordance with the further aspect of the present invention, there isprovided a method of positioning a drill guide over a drilling site onbone, comprising the steps of providing a drill guide of the type havinga housing, at least two axially extendable probes within the housing,and a drill guide extending through the housing. A first probe isextended from the retracted position to the extended position, andadvanced through the tissue until it contacts a bone. The second probeis thereafter extended from the retracted position to the extendedposition, until the second probe contacts the bone. If the firstextension of the second probe does not result in a contact, both probesare retracted within the housing, and the drill guide is translatedalong the sagittal or other axis. The first probe is thereafterreextended and the foregoing steps are repeated until both the first andsecond probes contact the bone.

In accordance with another aspect of the present invention, there isprovided a method of installing a bone anchor in a bone, utilizing thedrill guide defined above. In accordance with the installation method,each of the probes is sequentially extended and advanced through tissueas described until each of said probes is in contact with the bone. Adrill bit is thereafter advanced through the drill guide channel and ahole is drilled in the bone. The drill bit is thereafter withdrawn fromthe drill guide channel, and a suture anchor is advanced through thedrill guide shaft and into the bone.

In accordance with another aspect of the present invention, there isprovided a suture passer of the type adapted for releasably retaining asuture. The suture passer comprises a handle, and an elongate tubularprobe guide extending in a distal direction straight or curved from thehandle. An elongate probe is axially movably disposed within the tubularprobe guide, for motion between a first retracted position and a secondextended position in which the sharpened distal tip of the probe isexposed. An annular recess is provided on the probe, to cooperate withan opening on the tubular guide for receiving a suture. The probe isaxially movable with respect to the probe guide between a first positionin which the annular recess is aligned with the opening for receiving asuture therein, a second position wherein the annular recess is out ofalignment with the opening, to trap or retain a suture therein and athird position in which the distal probe tip is exposed.

In accordance with another aspect of the present invention, there isprovided a drape and exposure system comprising a vaginal drape,speculum and buttock plate for isolating the surgical field, providing amounting surface for surgical instruments, and opening the surgical areafor access. The vaginal drape comprises a large section of flexible,sterilizable material. Preferably, the drape has a large abdominal drapeconnected to a moisture barrier. The drape has a transparent surgicalwindow with an adhesive backing for viewing the surgical area.Alternatively, the window may be an opening through the drape devoid ofmaterial. An opening is provided below the window to allow a gloved handaccess through the drape to aid in placement of the drape. A vaginalflap or stretchable moisture-proof fabric is provided in the drape toallow a speculum to be placed therein.

Adhesive strips or velcro ties spaced around the window provide a meansto attach cables or tubes used for other ancillary surgical equipment.Further, a plate pocket is provided in the moisture barrier forplacement of the buttock plate.

The buttock plate is a mainly flat support surface. A mounting arm isprovided in one end of the plate, extending upwards about 50 mm andbeing about 50 mm in width. A bore is provided in the mounting arm toaccept a threaded knob for securing various tools to the plate.

The speculum is a member having a support stem with a slot therein toallow mounting to the plate, and a concave engaging member attached tothe top of the stem. The concave member is an arcuate shaped member forplacement in the vagina. Preferably, the concave member is inserted intothe vaginal flap of the drape and then extended into the vagina to aidin isolating the surgical field.

In accordance with yet another aspect of the present invention, there isprovided a suture support for providing a structure to which sutures maybe anchored inside the body so as to reduce trauma to body tissue. Inone form, the suture support comprises a circular plate about 15 mm indiameter and less than about 1 mm in thickness, having a small tabmounted on one side thereof for attachment of a suture. In another form,the support comprises a lattice constructed from wire having a diameterof about 1 mm. In another embodiment the support comprises a hub areawith spokes radiating outwardly thereto.

In accordance with another aspect of the present invention there isprovided a tissue staple and staple applier for use in suspending tissuein transvaginal bladder suspension procedures.

The tissue staples are arcuate elliptical structures preferably made ofspring wire. Sharpened ends are provided on the staple for penetrationof tissue. The body of the staple is located in between the ends and mayhave an enlarged center section in order to aid in distribution offorces on the tissue, and it may have openings to allow ingrowth oftissue.

The staple applier comprises a scissor like body provided with two armshaving handles at one end, and a pair of pressing support members at theother end. The arms are about 160 mm long and are rotatably attached toone another by a pin located at the end of the arms opposite thehandles.

The pressing members extend upwards from the pinned ends of the arms,mounted generally perpendicular to the longitudinal axis of the applier.The pressing members are arcuate in shape, their inside surface shapemirroring the shape of the staples, and their free tips being sharp toallow tissue penetration. The pressing members are designed such thatwhen the arms of the applier are open, the members are a distance awayfrom one another to allow the introduction of a staple therebetween.When the arms of the applier are pressed together, the members movetowards one another to press the sharp ends of the staple closed.

An opposing pair of staple removal prongs are mounted to, and between,the pressing members. The prongs are generally U-shaped shafts extendingfrom the members outwardly and then back in between the membersperpendicular to the axis of the applier. The prongs may be advancedtowards one another or drawn apart from each other by the movement ofthe arms.

There is a "C" clamp provided in accordance with another aspect of thepresent invention. The "C" clamp is an alternative to the drill guideand is designed for use with the buttock plate. The "C" clamp aids inlocating a drill bit through the pubic region.

The "C" clamp comprises a support arm, attachment member, and guide arm.The attachment member is a plate having a slot therein to allow passageof a knob therethrough for securing the clamp to the buttock plate. Thesupport arm is a primarily L shaped member extending from the attachmentmember to a distal end where a drill stop is located. The support arm isshaped so that when used in a bladder neck suspension procedure, in use,it extends from the attachment member located outside the body to itsdistal end located in the vagina. A bore is provided in the support armnear its connection with the attachment member for acceptance of theguide arm.

The guide arm is shaped like an inverted L, having a shaft-like stemwhich engages the support arm through the bore. The shaft is threadedand may be locked in relation to the support arm by knobs. The drillguide portion of the guide is a wide block. A drill guide bore and oneor more probe bores are located in the drill guide. Probes are providedfor engaging the probe bores. The probes and bores are similar to thosedescribed in the drill guide. The drill guide bore is oriented such thata line passing along its axis encounters the drill step on the supportarm.

In accordance with another aspect of the present invention, there isprovided a surgical bladder neck suspension procedure involving use ofthe tissue staples and drape and exposure system. This method isaccomplished entirely transvaginally through a tissue suspensionprocedure. In accordance with this procedure, the patient is firstplaced in the lithotomy position and sterily prepared. The vaginal drapeis positioned over the abdomen and secured thereto. The buttock plate isinserted into the buttock plate pocket, which lies under the patient andwith the guide arm extending upwards between the legs. The speculum isinserted into the vaginal flap and inserted into the vagina. Thespeculum is secured to the arm of the buttock plate.

A staple is loaded into the applier with the arms of the applier in theopen position. The pivot end of the applier is inserted into the vagina.Once aligned to one side of the bladder neck, the staple and supportmembers are pressed into the vaginal mucosa and upwards into theiliopectineal or other ligament. The arms of the applier are pressedtogether to close the staple. The applier may then be removed and theprocess repeated in the other side of the bladder neck.

In accordance with another aspect of the present invention, there isprovided a bladder neck suspension procedure involving use of the suturesupports, anchors, and the "C" clamp or drill guide or suture passer.

In accordance with this procedure, the drape and exposure system areprepared on the patient as before. The suture passer is passed throughan incision made over the pubic bone into the vagina. A suture that isattached to a suture support is captured in the suture channel of thepasser at the other. The passer is passed back out of the patient, untilthe suture is pulled slightly taut. The free end of the suture is thenaffixed to the pubic bone with a knot, plug, or anchor. The anchor maybe placed by pressing it into a hole drilled into the bone, as locatedby the "C" clamp or drill guide.

Alternatively, the drill guide or "C" clamp may be used to position adrill bit for drilling a passageway from the pubic area to the vagina.The free end of the suture is then passed through the drilled hole upfrom the vagina to the pubic area. The free end of the suture may thenbe tied off or affixed by a plug or anchor to prevent it from pullingback through.

In accordance with a further aspect of the present invention, there isprovided a surgical bladder neck suspension procedure, for the treatmentof stress urinary incontinence. In accordance with the method, atechnique of creating a suspension web comprising a plurality of lengthsof suture is constructed extending between the pubocervical fascia andthe pubic bone, on each of the right and left sides of the midline.Sutures are carried through tissue utilizing the suture passer disclosedherein, and sutures are tied down to the pubic bone utilizing a boneanchor positioned on each of the right and left sides of the midline bya drill guide as disclosed herein. Prior to tying, sutures areappropriately tensioned by advancing the suture around the suturetensioner disclosed herein and tying in a conventional manner.Thereafter, the suture tensioner is removed and the surgical siteprepared and closed in a conventional manner.

These and additional features and advantages of the present inventionwill become apparent from the detailed description of preferredembodiments which follows, when taken together with the attacheddrawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational partial cross sectional schematic view of adrill guide in accordance with the present invention.

FIG. 2 is an end view of the drill guide of FIG. 1.

FIG. 3 is a side elevational schematic view of the drill guide of FIG.1.

FIG. 4 is a front elevational view of the drill guide shown in FIG. 3.

FIG. 5 is a cross sectional view of a suture passer in accordance withthe present invention.

FIG. 6 is an enlargement of the distal tip of the suture passerillustrated in FIG. 5.

FIG. 7 is a perspective and detailed view of the suture tensioner inaccordance with the present invention.

FIG. 7a is a cross sectional side view of the suture tensioner of FIG.7.

FIG. 8 illustrates the location of incision sites for the method of thepresent invention.

FIG. 9a represents the positioning of the vertical passage of a Stameyneedle to just below the rectus fascia.

FIG. 9b illustrates the placement of a needle point on the underside ofthe pubic bone.

FIG. 9c represents the distal passage of the needle to the level of theintroitus.

FIG. 9d represents the withdrawal of the needle from the pubourethralligament and the path of the sweep back along the pubocervical fascia tothe area of the bladder neck and first entry site.

FIG. 10a illustrates the initial passage of the needle through thepubocervical fascia at point 1 (proximal and medial).

FIG. 10b represents the withdrawal of the suture through the pubicwound.

FIG. 10c illustrates the passage of the needle through the lateralaspect of the pubic wound and through the pubocervical fascia at point 2(proximal and lateral).

FIG. 10d illustrates the withdrawal of the suture into the retropubicspace.

FIG. 10e illustrates the passage of the needle and suture through point3 (distal and medial).

FIG. 10f illustrates withdrawal of the needle into the retropubic space.

FIG. 10g illustrates the passage of the needle through point 4 (distaland lateral).

FIG. 10h illustrates the withdrawal of the suture through the pubicwound.

FIG. 11a illustrates an early generation Mitek G1 anchor.

FIG. 11b illustrates a Mitek G2 anchor.

FIG. 12a illustrates drilling a hole in the pubic bone for placement ofan anchor.

FIG. 12b illustrates placement of an anchor with a suture into the pubicbone using an anchor inserter.

FIG. 12c illustrates extraction of the inserter leaving an anchor andsuture in place.

FIG. 13a is an end-on view of the urethra emphasizing volume ofpubocervical fascia captured and showing relative locations of sutureentry points.

FIG. 13b is a lateral view emphasizing the length of pubocervical fasciacaptured from the bladder neck to the pubourethral ligament.

FIG. 14 illustrates the tying of the suspension suture on pulp of fingerleaving a small amount of suture slack.

FIG. 15 illustrates the duration of hospitalization following surgery ofthe patients discussed in Example 1.

FIG. 16 illustrates the period of intermittent catheterization followingremoval of in-dwelling catheter for the patients discussed in Example 1.

FIG. 17 illustrates urinary urgency before and after surgery for thepatients discussed in Example 1.

FIG. 18 illustrates patient subjective satisfaction with results of theprocedure conducted in accordance with the present invention, forpatients discussed in Example 1.

FIG. 19 is a perspective view of an alternate embodiment drill guide ofthe present invention.

FIG. 20 is a front elevational view of the drill guide of FIG. 19.

FIG. 21 is a side view with a partial cross section of the drill guideof FIG. 19.

FIG. 22 is an enlarged side view of the end of the drill guide of FIG.21.

FIG. 23 is an enlarged end view of the drill guide of FIG. 21.

FIG. 24 is a top view of a vaginal drape of the present invention whenlaid flat.

FIG. 25 is a perspective view of the vaginal drape of FIG. 24.

FIG. 26 is a perspective view of a buttock plate in accordance with thepresent invention.

FIG. 27 is a side elevational view of a speculum of the presentinvention.

FIG. 28 is a front view of the speculum of FIG. 27 taken along lineC--C.

FIG. 29 is a perspective view of the buttock plate of FIG. 26 and thespeculum of FIG. 27 attached in combination.

FIG. 30 is a perspective view of one embodiment of a suture support inaccordance with the present invention.

FIG. 31 is a top view of a lattice suture support in accordance with thepresent invention.

FIG. 32 is a top view of an alternate embodiment of the lattice suturesupport in accordance with the present invention.

FIG. 33 is a perspective view of a spoked suture support in accordancewith the present invention.

FIG. 34 is a perspective view of an alternate embodiment of the spokedsuture support in accordance with the present invention.

FIG. 35 is a perspective view of a tissue staple in accordance with thepresent invention.

FIG. 36 is a perspective view of an alternate embodiment of the tissuestaple in accordance with the present invention.

FIG. 37 is a side elevational view of the staple applier with a staplebefore application, in accordance with the present invention.

FIG. 38 is a side elevational view of the staple applier and staple ofFIG. 37 in a closed position.

FIG. 39 is a top view of the staple applier of FIG. 38.

FIG. 40 is an elevational side view of a "C" clamp in accordance withthe present invention illustrated in body placement.

FIG. 41 is a perspective view of an alternate embodiment drill guide ofthe present invention.

FIG. 42 is a side view of the drill guide illustrated in FIG. 41.

FIG. 42a is an enlarged end view of the drill guide illustrated in FIG.42.

FIG. 43 is a front view of the drill guide illustrated in FIG. 41.

FIG. 44 is a top view of the drill guide illustrated in FIG. 41.

FIG. 45 is a cross-sectional view of an alternate embodiment suturepasser of the present invention.

FIG. 45a is an enlarged view of the distal tip of the suture passerillustrated in FIG. 45.

FIG. 46 is a top view of an alternate embodiment suture tensioner of thepresent invention.

FIG. 46a is a cross-sectional view of the suture tensioner illustratedin FIG. 46 through line a--a.

FIG. 47 is a side view of the suture tensioner illustrated in FIG. 46.

FIG. 47a is an enlarged view of the suture tensioner illustrated in FIG.47 at a--a.

FIG. 48 is a bottom view of the suture tensioner illustrated in FIG. 46.

FIG. 48a is an enlarged view of the suture tensioner illustrated in FIG.48 at a--a.

FIG. 49 is a end view of the suture tensioner illustrated in FIG. 46.

FIG. 50 is a perspective view of an alternate embodiment buttock plateand speculum of the present invention.

FIG. 51 is a perspective view of the buttock plate illustrated in FIG.50.

FIG. 52 is a side view of the buttock plate illustrated in FIG. 51.

FIG. 52a is a cross-sectional view of the buttock plate illustrated inFIG. 52 taken along line a--a.

FIG. 53 is a top view of the buttock plate illustrated in FIG. 51.

FIG. 53a is a cross-sectional view of the buttock plate illustrated inFIG. 53 taken along line a--a.

FIG. 54 is a bottom view of the buttock plate illustrated in FIG. 51.

FIG. 55 is a perspective view of the speculum illustrated in FIG. 50.

FIG. 56 is a rear view of the speculum illustrated in FIG. 55.

FIG. 57 is a side view of the speculum illustrated in FIG. 55.

FIG. 58 is a front view of the speculum illustrated in FIG. 55.

FIG. 59 is a top view of the speculum illustrated in FIG. 58.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

SUI is generally curable with any of a variety of surgical proceduresthat properly suspends the bladder neck. However, limitations of knownprocedures include 1) the extent of surgical morbidity 2) the everpresent threat of long term failures and 3) the reproducability betweendifferent surgeons.

Pereyra¹ introduced the transvaginal bladder neck suspension as a lessinvasive alternative to open retropubic procedures. Stamey² limitedmorbidity and improved the reproducibility of the transvaginal bladderneck suspension by introducing endoscopic control and confirmation ofsuture placement. Raz³ has improved reproducibility by introducing fullpalpatory control of needle passage through the retropubic space,thereby limiting disability through injury to the bladder or otherretropubic structures.

The distal passage of the suture passer disclosed herein or other needlefollowed by a sweep back to the bladder neck area described hereinaccomplishes a similar goal but without the necessity of entering theretropubic space. Passage of the needle point to the level of theintroitus along the underside of the pubic bone obviates the need toturn the needle down toward a bladder neck that has been digitallyelevated, thereby reducing the risk of bladder injury. Extraction of theneedle from the pubourethral ligament is necessary to allow a "capture"of the more pliable pubocervical fascia alongside the urethra. Thesubsequent, gentle sweep back of the needle along the surface of thepubocervical fascia provides an easy and safe means of introducing theneedle to the bladder neck area under the vaginal digital guidance.

Gittes and Loughlin⁵ have further popularized the technique of Pereyraand demonstrated an advantage of increased long-term efficacy bycreating an autologous bolster with the transvaginal passage of a curvedneedle. As an alternative manner of creating an autologous bolster, theproposed modification described herein uses the suture passer disclosedherein, or a Stamey needle through a suprapubic approach to carry thesuture through all of its vaginal passes. The full carriage of thesuture by the suture passer needle offers the benefits of 1) improvingaccuracy and reproducibility by allowing palpation of the needle at eachvaginal entry point in reference to the bladder neck and catheter, 2)potentially decreasing morbidity by reducing the risk of injury and/orirritation through inadvertent entry into any part of the urethra orbladder and 3) possibly contributing to long term efficacy by assuringthat a full thickness layer of pubocervical fascia is captured. Thistechnique permits the capture of a large lateral volume of pubocervicalfascia similar in an area to that available for suturing in an openretropubic urethropexy.

Leach⁴ has limited morbidity by decreasing post-operative pain and haspotentially improved long-term efficacy with pubic fixation of thesuspending sutures. However, the trochar needle passage through thepubic bone as described by Leach can be difficult through the limitedexposure that is used with some forms of endoscopic bladder necksuspension. Other various forms of pubic bone fixation have also beendescribed with transvaginal and open bladder neck suspensionsurgery⁶,7,8. To facilitate the anchoring of the suspensory suture tothe pubic bone with minimal soft tissue dissection, the present inventorhas used a new set of devices called the Mitek Anchor System. The latestgeneration of Mitek anchor, the G2, consists of a titanium body coupledto nickel-titanium arcs. These anchors have recently been used mostcommonly for tenodesis and ligamentous reconstruction of the shoulderand foot⁹,10.

In the present setting of bladder neck suspensions, the Mitek anchorwith attached suture is passed into a hole drilled in the pubic bone.Care must be taken to assure that the hole has been drilled into thepubic bone and not inferiorly through the tendon of the adductor longusor superiorly through the rectus fascia over the surface of the pubis.Proper location of the drill and placement of the bone anchor in thebone is facilitated by the drill guide illustrated in FIGS. 1-4 anddiscussed infra.

Once the anchor is passed into the bone, the anchor's unique memoryforces the arcs to spring open to their original shape and to engage inthe cancellous portion of the pubic bone. The complication of infectionwith use of the anchor has not been noted, which may, in part, be due tothe emphasis on broad spectrum antibiotics and sterile technique withuse of video endoscopy, when possible.

Anchor pubic bone fixation in one study by the inventor herein wasassociated with a limitation of post-operative pain allowing theprocedure to be performed on an outpatient basis in many of thepatients. Pubic anchor fixation may limit suspending suture pull throughat the level of the rectus fascia. Any assessment of resultantimprovement of long term efficacy will require longer follow-up.

Certain specific embodiments of the methods and devices of the presentinvention will follow, together with an example of the inventive bladderneck suspension procedure.

I. DRILL GUIDE

In accordance with one aspect of the present invention, there isprovided a drill guide for locating drill sites inside a patient's body.More specifically, the invention relates to a multi-probe bone locatorand drill guide centering device for locating a desired site on a bone,guiding a drill bit to the located site, retaining access to the sitefollowing drilling, and installation of a bone anchor for anchoringsutures.

Referring to FIG. 1, there is shown a surgical drill guide 10 inaccordance with one aspect of the invention. Generally, drill guide 10comprises a body 15 carrying two or more plungers 20, 21, each having abone probe 25, 26 at its end. A guide shaft 30 is located between twoadjacent bone probes 25, 26. Alternatively, one or more of the plungers20, 21 can be eliminated, so that one or more probes 25, 26 is directlymounted within or to body 15. Thus, in a simplified design, a drillguide channel is held in proximity to two or more elongate probes suchas hypodermic needles which are preferably axially movable.

Body 15 is the support structure for the drill guide 10. The body 15 mayhave any of a variety of exterior configurations; however, it ispreferred that the body be sufficiently axially elongate to facilitatewithdrawal of the sharpened distal tips 27, 28 of the probes 25, 26therein to minimize accidental needle sticks, and generally oval orrectangular in cross section. See, e.g., FIG. 2. The inside of the body15 has two or more identical chambers 35, 36 spaced apart from eachother to accommodate a drill guide shaft 30, as will be discussed.Preferably, an annular tissue compression portion 37 of body 15 adjacentthe guide shaft 30 extends slightly farther in the distal direction thanthe lateral sidewalls 38, 39 of the body 15. Tissue compression portion37 is optimally provided with a rough or serrated edge surface forcontacting the tissue surrounding the drill site as will be discussed.

Each chamber 35, 36 extends from the distal end of the body 15 to apoint near the proximal end of the body 15. In this manner, chambers 35,36 are provided with open distal ends to permit reciprocal axial motionof the bone probes 25, 26 therethrough. Proximal ends of chambers 35, 36are provided with a stop such as end walls 40, 41 having centralpassageways 42, 43 therethrough for movably accepting the plungers 20,21. Similarly, distal ends 44, 45 of chambers 35, 36 can be providedwith an end wall (not illustrated) having a probe opening therein, or apierceable septum for permitting passage of probes 25, 26 therethrough.

The exact distance between the axes of adjacent chambers 35, 36 dependson the procedure for which the device is to be used. For example, in abladder neck suspension procedure, the axes of chambers 35 should beseparated by a distance of no more than about 10 mm from theircenterlines, in an embodiment having coaxial probes and plungers, sothat the corresponding probe separation is also no more than about 10mm. Preferably, the separation between adjacent probes is within therange of from about 5 mm to about 15 mm.

Due to the bilateral symmetry of the illustrated embodiment, only oneside will be particularly described below. The plunger 20 preferablycomprises three main portions: an engaging knob 46, a main shaft 47 anda stop 50. The knob 46 is generally a cylindrical body attached to thetop of the shaft 47 and shaped for easy engagement with a thumb or hand.This knob 46 may be attached to shaft 47 in a variety of manners. Forexample, knob 46 is illustrated as having a recessed portion on itsdistal surface for accepting the proximal end of shaft 47. A screw 55,preferably flat headed, is then passed through the top of the knob intothe top of the shaft 47 to securely lock them together. Alternatively,the shaft 47, knob 46 and stop 50 can be integrally molded from any of avariety of thermoplastic materials well known in the art of surgicalinstrument manufacturing.

The plunger shaft 47 extends from the knob 46 through the opening 42 inthe proximal end wall 40 of the body 15 and into chamber 35. Shaft 47preferably is at least about 25 mm long from the distal surface of theknob 46 to the proximal surface of end wall 40 on body 15. In thismanner, the plungers 20, 21 have a sufficient range of axial travelbetween a first, retracted position in which the distal tips 27, 28 ofprobes 25, 26 are shielded, and a second, extended position in which thedistal tips 27, 28 of probes 25, 26 are exposed. It is contemplated,however, that the length of the shaft 47, probe 25 and axial travel mayvary depending on the intended procedure.

A stop 50 is positioned on the distal end of the shaft 47. The stop 50and shaft 47 may either be separately fabricated or may be fashionedfrom one piece of material such as by known molding or lathingtechniques. The illustrated stop 50 comprises a radially outwardlyextending portion of the plunger 20 which travels within the chamber 35to produce a transverse abutment surface 56. The stop 50 thus limits theproximal range of travel of the plunger 20 by engagement of the abutmentsurface 56 with the distal surface of end wall 40 of the body 15. Thestop 50 is preferably provided at its distal end with a connector suchas a standard luer for attachment of a probe 25. As will be appreciatedby one of skill in the art, any of a wide variety of interlocking orcomplementary surface structures can be devised to accomplish thefunction of stop 50.

In the illustrated embodiment, the probe 25 is inserted into a threadedcap 60. This cap 60 is preferably threaded on its interior surface sothat it may be attached to the correspondingly threaded distal end ofstop 50. Alternatively, the probe 25 can be connected to the stop 50 orshaft 47 such as by molding the proximal end of the probe 25 therein.

Each probe 25, 26 extends from the corresponding shaft 47 towards thedistal end of the chamber 35. Probe 25 may comprise standard hypodermictubing such as a standard needle, or a solid wire probe preferablyhaving a sharpened distal end.

The length of the probe 25 is preferably such that when the plunger 20is in a fully retracted state, the distal end of the probe 25 is spacedby at least about 4 mm from the open distal end of the chamber 35. Inthis manner, the probe end is protected against contamination and theuser of the drill guide 10 is protected against accidental probe sticks.Alternatively, the probes 25, 26 can be rigidly secured to the body 15or directly to a tubular drill guide shaft 30 as will be apparent to oneof skill in the art.

In an embodiment having axially movable plungers, the plunger 20 isnormally retracted proximally such that the distal tip 27 of probe 25connected thereto is recessed from the distal end 44 of the chamber 35.This position is preferably releasably maintained by engaging rods 65which are biased in the direction of annular recess 75 in the shaft 47of the plunger 20.

In the illustrated embodiment, annular recess 75 is provided in theplunger shaft 47 at a point adjacent the proximal end of the body 15.When the plunger 20 is retracted, recess 75 releasably receives rod 65.This rod 65 is biased such as by a spring so that it provides aninterference fit within recess 75 and holds the plungers 20 in theirretracted position. The rods 65 and springs are preferably mountedwithin a housing adjacent the proximal end of the body 15.

A drill guide shaft 30 extends axially in between the two chambers 35,36 containing the plungers 20, 21. Preferably, drill guide shaft 30 isdisposed approximately equidistant from the longitudinal axis of each ofchambers 35, 36 so that when each of the probes 25, 26 is in contactwith a bone, the axis of drill guide shaft 30 will be spaced well awayfrom the edge of the bone. In addition, in the illustrated embodiment,the axis of shaft 30 is offset laterally from the plane connecting theaxes of chambers 35 so that the axes of the two probes and the drillguide shaft 30 are disposed on vertices of a triangle. See FIG. 2. Thisconfiguration facilitates the use of a slot 31 extending the length ofguide shaft 30 for receiving a suture during the installation of thesuture anchor.

Drill guide shaft 30 is optionally surrounded by an elongate tubularbushing 80 extending throughout at least a portion of the body 15, andpreferably positioned so that the distal end of the bushing 80 isslightly recessed from the distal portion 37 of body 15. This bushing 80aids in properly centering a later installed drill bit and acts as achannel through which a suture anchor is introduced into the hole afterdrilling.

Referring to FIG. 3, there is disclosed a handle 90 connected to theoutside of the body 15 for maneuvering the drill guide 10. This handle90 is preferably generally tubular in shape, and approximately 10 mm indiameter for easy gripping by the user. The handle 90 as illustratedextends from its connection with the body 15 laterally away from saidbody, then upward and outward at an angle, and finally ends in agripping section 91 which extends generally along a perpendicular to theaxis of the body 15. This handle design permits the user to forcefullypress the drill guide 10 against the body, as well as to facilitatecontrolled translation of the drill guide along a sagittal axis.

The handle 90 may be connected to the body 15 in any of a variety ofconventional manners. In the illustrated embodiment, the handle extendsinto a small recess in the body 15 and then is locked in place such aswith a nut 85. The nut 85 as illustrated has a threaded portion forengaging the body, and a locking portion for pushing the handle 90 intothe body 15. Alternatively, the handle 90 can conveniently be integrallymolded with body 15, or secured thereto such as by thermal or solventbonding techniques or by adhesives well known in the art.

It is preferred that the components of the drill guide 10 be made of amaterial which is sterilizable, relatively rigid and biocompatible, suchas stainless steel or any of a variety of polymers conventionally usedfor medical instruments of the type designed to enter the sterile field.

The operation of the surgical drill guide 10 will now be described. Whenit is desired to locate a bone for attachment of a suture anchortherein, the drill guide is placed on the body over the area of thebone. The drill guide 10 is centered after visualization or digitalpalpation over the bone.

The user pushes one or both of the knobs 46 to distally extend at leasta first probe 25. The probe 25 is extended into the body by pushing theplunger 20 down, until either the plunger has been fully extended or thebone is contacted.

If the plunger extends fully without the probe contacting the bone, theprobe is retracted and drill guide 10 is then repositioned for anotherattempt at locating the bone.

When the first probe 25 does engage the bone, pressure is released fromthe knob 46. The user then extends the second probe 26 by pushing on thecorresponding knob of the second plunger 20. Once again, the secondprobe 26 will either engage the bone or the plunger 20 will fully extendwithout contact. If no contact is made by the second probe 26, bothprobes 25, 26 are retracted again by pulling upward on the appropriateknob. The drill guide 10 may then be translated along the sagittal axisand one or both probes reextended.

This process is continued until both probes 25, 26 contact the bone andare at approximately equal heights above the body of the drill guide. Atthis time, the user will be assured that the bone has been located andthat the guide shaft 30 is properly centered over the bone.

A drill bit is then extended through the drill bushing 80 and into thepatient. The drill bit is used to drill through adjacent tissue andproduce a small hole in the bone. Preferably, a step drill or otherlimiting structure is utilized for producing a hole having apredetermined and reproducible depth into the bone. For installation ofthe preferred Mitek G2 anchors disclosed herein, a 2.5 mm diameter drillbit is used to produce a hole of 15 mm depth into the bone.

The desirability of having a tissue compression portion 37 which extendsdistally slightly beyond the distal end of the adjacent body is nowapparent. At the time the drill bit is retracted, the hole drilled wouldnormally close upon itself because of the resiliency of the surroundingtissue. However, by maintaining pressure on the body 15 in the directionof the bone, the tissue compression portion 37 tends to compress theadjacent tissue thereby minimizing migration and maintaining the holeopen.

In this manner, the tissue located directly under the guide shaft isprevented from closing, and the anchor can be readily advanced throughguide shaft 30 and into the bone. Even without distally extending tissuecompression portion 37, installation of the anchor is greatly simplifiedusing the drill guide of the present invention because the axis of drillguide shaft 30 remains directed at the drill hole.

Following retraction of the drill bit, a suture anchor is advanced intothe body through the drill bushing 80 and then connected within the holein the bone. An installation tool which facilitates holding the anchorbody by means of an interference fit at the gripping point and guidingsaid anchor through the guide hole and compressed tissue into the bonehole is preferably utilized. The suture, typically previously connectedto the anchor, is permitted to trail out through the slot 31 providedfor that purpose.

Referring to FIGS. 19-23, there is shown an alternative embodiment of adrill guide for use in locating drill sites inside a patient's body. Asillustrated, the drill guide 210 comprises a body 215 carrying one ormore probes 225, 226. A drill guide bore 230 is preferably locatedbetween the bone probes 225, 226.

The body 215 is the support structure for the drill guide 210. The body215 may have any of a variety of exterior configurations; however, it ispreferred that the body be sufficiently axially elongated to facilitatewithdrawal of the sharp distal tips 227, 228 of the probes 225, 226therein to minimize accidental needle sticks. Body 215 is generally ovalor rectangular in cross section.

Body 215 is provided with one or more bores 235, 236 extendingtherethrough (FIG. 20). As illustrated, the bores 235, 236 are spacedapart from each other to accommodate a drill guide bore 230. It iscontemplated that the drill guide bore 230 may coincidentally be one ofthe bores 235, 236, in which case the spacing between bores 235, 236 canbe reduced. If only one probe 225 is used, there may only be one bore235, and this bore 235 may coincidentally be the drill guide bore 230also.

Preferably, the distal end 237 of the body 215 is provided with a numberof serrations 234 (FIGS. 22 and 23). In the illustrated embodiment,serrations 234 are located approximately 1 mm apart and run generallyparallel to the longest dimension longitudinally across the face ofdistal end 237. The serrations 234 are sharp ridges formed betweencurved grooves which have a diameter of about 0.5 mm and extend into theface of the distal end 237.

The exact distance between the axes of the adjacent bores 235, 236depends on the procedure for which the device is to be used. Asillustrated in FIG. 23 and as used in a bladder neck suspensiontechnique, the axes of the bores 235, 236 should be separated by adistance of no more than about 9 mm between centerlines. In this manner,the corresponding probe separation in a two probe embodiment is also nomore than about 9 mm. While this is the preferred separation distance,it is also possible for the separation to be anywhere within the rangeof between about 5 mm and about 10 mm.

Each probe 225, 226 preferably comprises a unitary element such as awire or needle. An engaging knob 246 is mounted to the proximal end ofeach probe 225, 226. Knob 246 is a generally cylindrical body which isshaped for easy engagement with a thumb or hand. Knob 246 may beattached to the probes 225, 226 in any of a variety of manners wellknown in the art. As illustrated, the knob 246 is stainless steel, butmay be molded from a thermoplastic material, and provided with a recessfor receiving the top of the corresponding probe 225, 226.

The probes 225, 226 extend distally from each knob 246 and into the body215 through the bores 235, 236. The probes 225, 226 are preferably atleast approximately 75 mm long from the distal surface of the knobs 246to their tips 227, 228. In addition, the axial length of the body 215 iswithin the range of from about 50 mm to about 60 mm long, and preferablyabout 50 mm long. The probes 225, 226 thus have a sufficient range ofaxial travel between a first retracted position in which the distal tips227, 228 of the probes 225, 226 are shielded inside the bores 235, 236,and a second extended position in which the distal tips of the probesare exposed. It is contemplated, however, that the length of the probes225, 226 and axial travel may vary depending on the intended procedure.

The knobs 246 act as limits on distal travel of the probes 225, 226, byengagement with the proximal surface of the end wall 240 of the body215.

The length of the bores 235, 236 is preferably such that the distal tips227, 228 of the probes 225, 226 are spaced by at least about 3 mm fromthe open distal end of the bores 235, 236 at the distal end 237 of thebody 215 when the probes are retracted. In this manner the probe end isprotected against damage, and the patient and user of the drill guide210 are protected against accidental probe sticks.

Probes 225, 226 are preferably provided with a means for providing abias in the proximal direction, to releasably retain the probes in theretracted state when not in use. In addition, sufficiently strongbiasing means can assist in retraction of the probe from body tissue.The bias may be provided in any of a variety of ways known in the artsuch as with the use of coil springs. Preferably, a tapered conicalsection (not shown) is provided on the body of the probes 225, 226. Amatching tapered step (not shown) is provided in each bore 235, 236. Theconical section and step are arranged to engage each other so that theprobes 225, 226 are maintained in a retracted state during non-usebecause of friction. The probes 225 and 226 may easily be released uponlight finger pressure on the knobs 246. Alternatively, any of a varietyof releasably retention structures for opposing a bias may be utilizedas will be apparent to one of skill in the art.

As illustrated in FIGS. 19, 20 and 23 a drill guide bore 230 extendsaxially in between the bores 235, 236 which contain the probes 225, 226.Drill guide bore 230 in the illustrated embodiment is essentiallycoplanar with bores 235, 236. However, depending upon the desireddiameter of drill guide bore 230 and spacing of bores 235, 236, drillguide bore 230 can be offset from the plane of bores 235 and 236. Ingeneral, the minimum diameter of drill guide bore 230 is set by thedesired drill bit size and by the desired bone anchor, as has beenpreviously discussed. Typical bone anchors of the type used herein areon the order of 2 mm in diameter.

Preferably, the drill guide bore 230 is disposed approximatelyequidistant from the longitudinal axis of each of the bores 235, 236 sothat when each of the probes 225, 226 is in contact with a bone, theaxis of the drill guide bore 230 will be spaced well away from the edgeof the bone. In addition, the drill guide bore 230 preferably has a slot231 extending the length of the guide bore 230 for receiving a suture,and for removing the drill guide after an anchor and suture have beeninstalled.

As illustrated in FIG. 21, a handle 290 is connected to the outside ofthe body 215 for maneuvering the drill guide 210. The handle 290preferably comprises two sections: a gripping portion 291 and anattachment portion 292. The attachment portion 292 extends from itsconnection with the body 215 upward at an angle of about 45 degrees toits connection with the gripping portion 291 which extends generallyalong a line parallel to the axis of the body 215.

The attachment portion 292 can be connected to the body 215 in any of avariety of conventional manners. In the illustrated embodiment, theattachment portion 292 is brazed to the outside of the body 215. Theattachment portion 292 could alternatively be integrally molded with thebody 215, or it could be otherwise secured to the body 215 byconventional welding, solvent, thermal or adhesive bonding techniques,or fastened with screws or the like.

The gripping portion 291 is preferably approximately 140 mm in lengthand about 20 mm wide. The gripping portion is about 30 mm thickthroughout most of its length, however, near its connection with theattachment portion 291 it tapers at approximately a 45° angle to a thinsection of 10 mm thickness and 30 mm length which acts as a thumb restfor the user.

The gripping portion 291 is preferably rotatable about an axis which isperpendicular to the axis of the probes 225, 226. The gripping portion291 is thus, as illustrated, mounted on a pin 293 which extends from thebottom surface of the attachment portion 292 into a matching hole in thegripping portion 291 and clamped with a centrally located screw.

It is preferred that the components of the drill guide 210 as embodiedbe made of a material which is sterilizable, relatively rigid andbiocompatible, such as stainless steel or any of a variety of polymersconventionally used for medical instruments of the type designed toenter the sterile field.

The operation of drill guide 210 is the same as that described for theembodiment illustrated in FIGS. 1-4. Operation of the single probeembodiment (not illustrated), will be apparent to one of skill in theart in view of the disclosure herein.

If the drill guide 210 has only one probe, the guide is pressed firmlyagainst the tissue in the area over where the bone is believed to belocated. The probe 225 is pressed into the body with the knob 246. Ifthe probe 225 does not contact bone firmly, the guide 210 is moved andthe probe is re-inserted. Once contact has been established, the probe225 may be removed from the bone 235 and the drill bit is preferablyinserted through the same bore for drilling the hole. Once drilled,pressure is maintained on the drill guide 210 in the distal direction.Tissue will be restrained from occluding the hole by the serrations 234located on the distal end 237 of the probe 225.

Referring to FIGS. 41-44, there is shown yet another alternateembodiment of a drill guide for use in locating drill sites inside apatient's body. This drill guide 710 is similar to that described above,except that this drill guide 710 is designed to be disposable, having adesign which is easy to manufacture, and yet fully functional. Asillustrated, the drill guide 710 comprises a body 715 carrying one ormore probes 725, 726. A drill guide bore 730 is preferably locatedbetween the bone probes 725, 726.

The body 715 is the support structure for the drill guide 710. The body715 may have any of a variety of exterior configurations; however, onceagain it is preferred that the body be sufficiently axially elongated tofacilitate withdrawal of the sharp distal tips 727, 728 of the probes725, 726 therein to minimize accidental needle sticks. Body 715 ispreferably oval or elliptical in cross section preferably being about7.5 mm wide and 14 mm long on its bottom surface.

Body 715 is provided with one or more bores 735, 736 extendingtherethrough. As illustrated, the bores 735, 736 are spaced apart fromeach other to accommodate a drill guide bore 730. It is contemplatedthat the drill guide bore 730 may coincidentally be one of the bores735, 736, in which case the spacing between bores 735, 736 can bereduced. If only one probe 725 is used, there may only be one bore 735,and this bore 735 may coincidentally be the drill guide bore 730 also.

Preferably, the distal end 737 of the body 715 is provided with a numberof serrations 734 (FIGS. 42 and 42a). In the illustrated embodiment,serrations 734 are located approximately 1 mm apart and run generallyparallel to the longest dimension longitudinally across the face ofdistal end 737. The serrations 734 are sharp ridges formed betweencurved grooves which have a diameter of about 0.5 mm and extend into theface of the distal end 737.

As set forth above, the exact distance between the axes of the adjacentbores 735, 736 depends on the procedure for which the device is to beused. As illustrated in FIG. 41 and as used in a bladder neck suspensiontechnique, the axes of the bores 735, 736 are separated by a distance ofabout 7 mm between centerlines. In this manner, the corresponding probeseparation in a two probe embodiment is also no more than about 7 mm.While this is the preferred separation distance for this embodiment, asdiscussed above, it is possible for the separation to be anywhere withinthe range of between about 5 mm and about 10 mm.

As best illustrated in FIG. 41, each probe 725, 726 preferably comprisesa unitary element such as a wire or needle. An engaging knob 746 islocated at the proximal end of each probe 725, 726. Knob 746 is agenerally disc shaped body which is designed for easy engagement with athumb or fingers. Knob 746 may be attached to the probes 725, 726 in anyof a variety of manners well known in the art. As illustrated, the knob746 is manufactured of a thermoplastic material, and provided with arecess and located about the curved top end of the corresponding probe725, 726.

The probes 725, 726 extend distally from each knob 746 and into the body715 through the bores 735, 736. As stated above, the probes 725, 726 arepreferably at least approximately 75 mm long from the distal surface ofthe knobs 746 to their tips 727, 728. In addition, the axial length ofthe body 715 is within the range of from about 50 mm to about 60 mmlong, and in this embodiment is preferably about 50 mm long. The probes725, 726 thus have a sufficient range of axial travel between a firstretracted position in which the distal tips 727, 728 of the probes 725,726 are shielded inside the bores 735, 736, and a second extendedposition in which the distal tips of the probes are exposed. It iscontemplated, however, that the length of the probes 725, 726 and axialtravel may vary depending on the intended procedure.

Guide members 780 also engage the knobs 746 and act to limit the distaltravel of the probes 725, 726 and prevent twisting of the knobs 746. Theguide members 780 are rigid members which each travel in slots 781located along the outside of the body 715 which are connected to eachcorresponding bore 735, 736. The members 780 have a length which, whencoupled with the slots 781 is such that when the members 780 engage theend of the slots 781 to limit the travel of the probes 725, 726 theprobes have extended out of the body 715 a sufficient distance to allowbone location. As illustrated, the members 780 are formed integrallywith the probes 725, 726 as one piece, the probes 725, 726 circling backthrough the knob 746 and running parallel thereto for a distance, untilconnecting back to each probe 725, 726.

The length of the bores 735, 736 is again preferably such that thedistal tips 727, 728 of the probes 725, 726 are spaced by at least about3 mm from the open distal end of the bores 735, 736 at the distal end737 of the body 715 when the probes are retracted. In this manner theprobe end is protected against damage, and the patient and user of thedrill guide 710 are protected against accidental probe sticks.

Probes 725, 726 may be provided with a means for providing a bias in theproximal direction, to releasably retain the probes in the retractedstate when not in use. In addition, sufficiently strong biasing meanscan assist in retraction of the probe from body tissue. The bias may beprovided in any of a variety of ways known in the art such as with theuse of coil springs. Alternatively, any of a variety of releasablyretention structures for opposing a bias may be utilized as will beapparent to one of skill in the art.

As illustrated in FIGS. 41 and 43 a drill guide bore 730 extends axiallyin between the bores 735, 736 which contain the probes 725, 726. Drillguide bore 730 in the illustrated embodiment is essentially coplanarwith bores 735, 736. However, depending upon the desired diameter ofdrill guide bore 730 and spacing of bores 735, 736, drill guide bore 730can be offset from the plane of bores 735 and 736. In general, theminimum diameter of drill guide bore 730 is set by the desired drill bitsize and by the desired bone anchor, as has been previously discussed.Typical bone anchors of the type used herein are on the order of 2 mm indiameter.

Preferably, the drill guide bore 730 is disposed approximatelyequidistant from the longitudinal axis of each of the bores 735, 736 sothat when each of the probes 725, 726 is in contact with a bone, theaxis of the drill guide bore 730 will be spaced well away from the edgeof the bone. In addition, the drill guide bore 730 preferably has a slot731 extending the length of the guide bore 730 for receiving a suture,and for removing the drill guide after an anchor and suture have beeninstalled.

As best illustrated in FIGS. 41 and 42, a handle 790 is connected to theoutside of the body 715 for maneuvering the drill guide 710. The handle790 preferably comprises two sections: a gripping portion 791 and anattachment portion 792. The attachment portion 792 extends from itsconnection with the body 715 upward at an angle of about 58 degrees toits connection with the gripping portion 791 which extends generallyalong a line perpendicular to the axis of the body 715. As illustrated,the attachment portion 791 in preferably molded from thermoplastic, andtherefore has a rigid top and bottom support connected by a number ofribs.

The attachment portion 792 can be connected to the body 715 in any of avariety of conventional manners. In the illustrated embodiment, theattachment portion 792 is integrally molded with the body 715 of athermoplastic, but it could be otherwise secured to the body 215 byconventional welding, solvent, thermal or adhesive bonding techniques,or fastened with screws or the like, depending on the materials used.

The gripping portion 791 of this embodiment is preferably approximately95 mm in length and primarily cylindrical, having a diameter of about 25mm. The gripping portion tapers slightly near its connection with theattachment portion 791.

As discussed above with the other embodiment, it is preferred that thecomponents of the drill guide 710 as embodied be made of a materialwhich is sterilizable, relatively rigid and biocompatible. In order forthe drill guide 710 to be economically producible for disposable use, itis preferred that the components thereof (excluding the probes 725, 726,which are preferably manufactured of stainless steel) be made of any ofa variety of polymers conventionally used for medical instruments of thetype designed to enter the sterile field. In particular, thethermoplastic Cycolac GSM 2679F made by General Electric Plastics hasbeen found suitable, which is Acrylonitrile Butadiene Styrene (ABS)material. If it is desired that the drill guide 710 not be disposable,it can be made of stainless steel.

Once again, the operation of drill guide 710 is the same as thatdescribed for the embodiments illustrated in FIGS. 1-4 and FIGS. 19-23,and description there will be understood to apply equally well to thisembodiment.

II. SUTURE PASSER

In accordance with another aspect of the present invention, there isprovided a suture passer adapted for grasping and passing internalsutures, such as to construct the sling disclosed herein. The suturepasser of the present invention is particularly suited for use inconnection with such surgery as the bladder suspension proceduredisclosed herein, where sutures are required to be advanced andwithdrawn without direct visualization and through relatively longdistances. Alternatively, the suture passer may be used with othertechniques such as Pereyra, Stamey and Gittes methods.

The suture passer of the present invention enables the clinician toavoid accidental damage to the patient's internal structures andaccidental needle sticks to himself and operating room personnel. Thepassive retraction of the needle point within the cannula, which will bediscussed, facilitates the foregoing safety features, and secure captureof the suture material. The ability to advance the cannula with a blunt(retracted needle tip) end also facilitates internal suturing withoutdirect visualization. Safe direct tactile feedback is provided alongorgan surfaces to localize placement of the suture. These and otherfeatures and advantages of the suture passer of the present inventionwill be discussed below.

Referring to FIG. 5, there is disclosed a suture passer 105 inaccordance with one aspect of the present invention. In general, suturepasser 105 comprises a handle 110, an axially movable probe 115, and aprobe guide 125 having a suture channel 130. Details of suture channel130 and related structures can be seen in the enlarged view in FIG. 6.

Handle 110 serves both as a gripping area for the user and as a supportstructure for the suture passer 105. Handle 110 preferably comprises ahollow tubular body having proximal end wall 111 and distal end wall112. Handle 110 is preferably of such a size to be easily gripped by auser. A handle 110 being at least approximately 0.75 inches (20 mm) indiameter and 4 inches (110 mm) in length has been found to work well.Preferably, handle 110 is provided with knurling or other surfacetexturing to produce a high friction gripping surface.

A support 135 is preferably mounted such that it extends from the distalend of the handle 110 to provide a mounting support for probe guide 125.The support 135 as illustrated is provided with a generally cylindricalproximal section 137 for engagement within the distal end of the handle110 and a tapered distal section 139 for securing probe guide 125. Thesupport 135 acts as a transition member from the handle 110 to supportthe probe guide 125.

The probe guide 125 comprises an elongated tubular member which is atits proximal end inserted within or secured to the support 135. Theprobe guide 125 may be fixed to the support 135 in any variety ofmanners, including brazing, threading or others known in the art.

The probe guide 125 extends distally therefrom and is preferably withinthe range of from about 6 inches to about 8 inches in length and may bestraight or curved. The length of probe guide 125 may vary, of course,depending on the exact intended procedure.

At its distal end, the probe guide 125 is provided with a smooth taperedengaging face 140. The distal extreme of tapered face 140 is slightlyrounded or polished so that it can be pressed lightly against and sweptalong the surface of tissue such as the pubocervical fascia withoutcutting or traumatizing the tissue.

The probe guide 125 is preferably no more than about 0.1 inches (2.5 mm)in diameter and is provided with at least one central lumen foracceptance of an axially movable probe 115. An elongate probe 115 ismounted within the handle 110 and extends through the support 135 andthe probe guide 125. Probe 115 is preferably provided at its proximalend with a relatively large diameter body portion 116 adapted forreciprocal motion within tubular handle 110. Body portion 116 ispreferably provided with a slightly smaller diameter recessed portion117 for receiving a return spring 142 which biases the probe in theproximal direction. Alternatively, any of a variety of means can beutilized to provide a proximal bias on probe 115.

The length of body portion 116 is less than the axial length of thecavity within handle portion 110 so that the body portion 116 has anaxial range of motion within the range of from about 2 mm to about 10mm, and preferably about 0.12 inch (3 mm). The proximal end wall 136 ofsupport 135 which extends into the handle 110 acts as one limiting stopfor distal travel of body 116. The distal surface of end wall 111 limitsproximal travel of body 116. Spring 140 pushes against an annularshoulder 118 on body portion 116, biasing the probe 115 proximally.

The distal end of probe 115 is provided with a sharpened tip 120. Spring142 normally biases tip 120 towards a first retracted position withinthe distal end of probe guide 125. Axial distal force on body portion116 extends tip 120 into a second exposed position as illustrated inFIGS. 5 and 6. Although the probe 115 may be actuated in any number ofways, such as by use of a knob or button, it is presently preferred thata rotatable cam 122 be used.

The cam 122 is attached to a post 150 which extends proximally from thehandle 110. The cam 120 is rotatably mounted about a pin 155 whichextends in an axis perpendicular to the longitudinal axis of the probe115. The proximal end of the body portion 116 has a rod 145 whichextends proximally through an opening 147 in the proximal end wall 111of the handle 110.

The cam 122 has at least a two position engaging surface which, whenrotated into position, engages the rod 145 of the body 116. In a firstposition, the bias imposed by return spring 142 is overcome and thesharpened distal end 120 of probe 115 is extended outwardly from theprobe guide 125. In a second engaged position, the distal end 120remains within probe guide 125, but the suture lock is actuated as willbe discussed. In a third position, the distal tip 125 is fully retractedwithin guide 125, and the suture lock is open such as for receiving orreleasing a suture.

The cam 120 is preferably provided with an actuator portion 156 whichextends radially outwardly and which may be used by the operator forrotating the cam 122.

A suture channel 130 is provided near the distal end of probe guide 125.Channel 130 cooperates with an annular or slotted recess 160 near thedistal end of the probe 115. Suture channel 130 comprises an opening inthe probe guide 125 which extends radially inwardly into the guide 125and then generally axially along the guide 125 towards the distal end.The annular or slotted recess 160 in the probe 115 is located such thatwhen the probe 115 is retracted to the proximal limit, the recess 160and the opening in the channel 130 are aligned for receiving a suturetherein.

At least a portion of the suture channel 130 extends generally axiallyalong the guide 125 such that when a suture 165 is located in the recess160 of the probe 115, the probe 115 may be extended to an intermediate,"locked" position, or to a distal position in which tip 120 is exposedoutside of the probe guide 125. In this extended probe position and atall positions between the proximal and distal limits, the suture 165 istrapped within the recess 160 in the probe 115.

As with the drill guide discussed supra, it is preferred that thisinstrument be manufactured from a sterilizable material havingsufficient rigidity for its intended purpose. Many acceptable materialsare well known in the art, such as stainless steel for the needle andneedle guide, and stainless steel or a plastic for the handle portion.

The suture passer 105 is operated first by rotating the cam 122 thatengages the rod 145 and extends the probe end 120 distally of the probeguide 125. The passer 105 is then extended into a patient's body bygripping the handle 110 and pushing the free end of the probe guide 125into the body and through the layers of tissue in the same manner as theStamey needle discussed in Example I, infra, and illustrated in FIGS.9A-10H. The cam 122 is then released and passively rotates to itsneutral position 148 via action of spring 142 against the body 116 inturn pressing the rod 145 proximally against the cam ramp 149. The probeend 120 is thereby retracted into the probe guide 125 so that the suturepasser can be manipulated without injury to surrounding tissue whilekeeping the suture 165 trapped in channel 130.

The suture passer 105 is then guided as discussed in Example I, to thedesired capture point (see FIG. 10A) and the cam 122 rotated to aposition in which the suture channel 130 is aligned with the recess 160of the probe 115. A length of suture 165 is transvaginally introduced atthe introitus and digitally pressed against the outside of the probeguide 125 at a point proximal to the suture channel opening 130.

The suture 165 is then moved proximally until the suture 165 falls intothe channel opening 130 and the annular or slotted recess 160 on theprobe 115. The cam 122 is then operated so that rod 145 slides down camramp 149 under the bias of spring 142. At this time, the suture 165 isheld securely within the channel 130, and distal tip 120 is retractedwithin guide 125. Preferably, channel 130 and recess 160 are dimensionedso that the suture 165 is slidably retained therein. The passer 105 maythen be retracted from the body, thus drawing the suture 165 from insidethe body. The construction of a bladder neck suspension web utilizingthe suture passer will become apparent from the method disclosed inExample I, infra.

An alternate embodiment suture passer 805 is illustrated in FIGS. 45 and45a. This passer 805 is very similar to the passer 105 described above,and therefore will not be redescribed in full detail here. This passer805 is particularly suited and designed to be disposable. It isunderstood, however, that the description above, to the extent possible,applies to this embodiment of the passer 805 as well.

As illustrated, the passer 805 comprises a handle 810, an axiallymovable probe 815, and a probe guide 825 having a suture channel 830.The main difference between this passer 805 and that described above 105is that the probe guide 825 of this embodiment 805 is slightly bowed. Asillustrated, the guide 825 preferably has a diameter of approximately2.4 mm, and is preferably approximately 178 mm long, and is bowed in onedirection such that the free end of the guide 825 is located off of theaxis of the passer 805.

Further, an actuator lever 822 is used to actuate the probe 815 insteadof the cam 122 described in conjunction with passer 105. This lever 822is similar to the cam 122 described above, except that it includes aprotruding engaging portion 890 which extends for engagement by a thumbor hand. Preferably, the lever 822 is rotatably mounted about a pin (notshown) which extends in an axis perpendicular to the longitudinal axisof the probe 815. The lever 822 is directly connected to a rod (notshown) which is located on the proximal end of the probe 815, similar tothat described above.

The lever 822 allows the user to actuate the probe 815 by manipulatingthe engaging portion 890. When it is desired to extend the probe 815,the lever 822 is positioned such that the engaging portion 890 is in anearly upright position, or perpendicular to the axis of the probe 805.Alternatively, when it is desired to retract the probe 815, the engagingportion 890 of the lever 822 is pressed rearwardly with respect to theprobe 822 until the desired amount of probe 815 retraction is achieved,or until the movement of the probe 815 is stopped by the proximal end ofthe probe 815 contacting the inside end of the housing 810.

In order for this passer 805 to be disposable, it is desired that itscomponents, (except for the guide 825, probe 815, and an internalspring, which are preferably manufactured of stainless steel) be made ofa suitable thermoplastic. In particular, the thermoplastic Cycolac 2679Fmade by General Electric Plastics has been found suitable, which isAcrylonitrile Butadiene Styrene (ABS).

Use of the passer 805 is similar to that described above in conjunctionwith passer 105, and therefore will not be described again here.

III. SUTURE TENSIONING

In accordance with another aspect of the present invention, areproducible technique of tying the suspending suture is described.Tying down on something with the approximate dimension of the distalpulp of an index finger leaves a small amount of slack in the suturewhich permits a controlled and limited suspension of the bladder neckwhen suspended in this way. The slack is acceptable because of the largevolume of pubocervical fascia lending support to the bladder neck. Inthe prior art, it has been observed to be relatively easy to placeexcessive tension on the bladder neck. Chronic urinary retention isavoided by utilizing the suture tensioner disclosed herein, and thechance of acute retention is minimized, thereby promoting a reduction inperiods of indwelling and intermittent catheterization.

Chronic retention with endoscopic bladder neck suspension has beenreported in as many as 5 to 18.9 percent of patients in otherseries¹¹,12. Excessive tension with overcorrection of the bladder neckis also known to account for bladder instability¹³. In the study by thepresent inventor, urinary urgency and urgency incontinence diminishedfollowing surgery with the limitation of suture tension describedherein. This reduction in irritative urinary symptoms was alsoassociated with the lateral placement of the pubocervical sutures.

The period of hospitalization was reduced within the tension limitinggroup in the experimentation conducted by the inventor herein. A limiton suture tension may be found, over time, to decrease suture pullthrough at the pubocervical fascia and, therefore, enhance long termefficacy. The one failure in the study conducted by the present inventoroccurred in a patient who had the suspending suture tied in the priorart tighter and more arbitrary manner.

The modifications described herein attempt to further reduce thelimitations of the present forms of bladder neck suspension in a selectgroup of patients with SUI (grade 1 and 2). Safety and short termefficacy of the modifications were good. Patient inconvenience in termsof the period of hospitalization and intermittent catheterization waslimited. The period of indwelling catheter drainage will be shortened inthe future. Satisfaction in the patient group was high. The priority ofimproved long term efficacy is stressed in these techniques that allowthe accurate and secure placement of suspending sutures in areproducible manner that minimizes the tensions placed upon thosetissues that are suspended.

As an alternative to tying down against the index finger, there isprovided herein a suture tensioner for providing consistent, repeatableamounts of slack (tension) in the suture sling. As with the use of theindex finger described supra, the use of the suture tensioner minimizespost-operative urinary blockage caused by excessive tension, andminimizes post-operative urinary incontinence due to insufficienttension. In addition, the suture tensioner permits the visualization ofsuture knots during tying, thereby ensuring consistency of alignment andtension of knot loops.

Referring to FIG. 7, there is disclosed one embodiment of a suturetensioner in accordance with the present invention. The suture tensioner170 may be constructed in any of a variety of ways which will be wellunderstood by one of skill in the art of constructing medical devices,such as by injection molding or lathing processes.

The suture tensioner 170 comprises generally an elongate handle 172 anda body portion 174. The handle 172 may be integrally formed with thebody 174, or may be separately produced and affixed such as by insertioninto an opening 173 in the body 174, and retained therein such as bythreads, adhesives or other conventional means.

The main body 174 comprises a generally cylindrical mass, having arelatively blunt distal end 176 and an annular or semi-annular recess178 extending about an axis of the main body 174 which is generallyperpendicular to the longitudinal axis of handle 172. Otherconfigurations will also become apparent to one of skill in the art inview of the present disclosure.

In the illustrated embodiment, the annular recess 178 extends into themain body 174 to a minimum depth of about 0.2 mm to 3.0 mm, and has aradius of approximately 0.5 mm. These dimensions have been foundsuitable for holding the first throw of the knot while maintainingsuture tension, when tying down the sutures typically utilized in thebladder suspension procedure, which typically have a diameter of about0.5 mm. The main body 174 has an axial length of about 15 mm, and adistance between distal end 176 of main body 174 and annular recess 178of about 8 mm.

The handle 172 extends into the main body 174 to a depth ofapproximately 14 mm, and the remaining exposed handle has a length ofapproximately 100 mm. The diameter of the main body 174 is approximately16 mm.

In addition to providing a reproducible amount of slack in the tiedsuture, the use of suture tensioner 170, spaces the knot tying regionapart from the tissue during tying. The suture tensioner 170 also allowsvisualization of the knot while being tied. Further, the suturetensioner 170 allows the user to apply variable tension in relation tothe size of the suture body.

Referring to FIGS. 46-49, there is disclosed another alternateembodiment of a suture tensioner in accordance with the presentinvention. The suture tensioner 1070 may be constructed in any of avariety of ways which will be well understood by one of skill in the artof constructing medical devices, such as by injection molding or lathingprocesses. Preferably, this tensioner 1070 is designed to be disposable,and therefore is preferably made of thermoplastic material. Inparticular, the thermoplastic Cycolac 7629F made by General Electric hasbeen found suitable, as have acrylonitrile, butadiene, and styrene.

The suture tensioner 1070 is similar to the passer 170 described above,and comprises generally an elongate handle 1072 and a body portion 1074.The handle 1072 is preferably integrally formed with the body 1074,although it may be separately produced and affixed such as by insertioninto an opening 1073 in the body 1074, and retained therein such as bythreads, adhesives or other conventional means.

As illustrated in FIG. 46a, the handle 1072 preferably has an I-beamshaped cross-section. Reinforcing ribs 1071 are preferably provided toadd rigidity to the handle 1072. The handle 1072 preferably tapers atits intersection with the body 1072, and has at its end opposite themain body 1074 a tapered section to allow easy gripping and a notch1075. The notch 1075 is useful in catching sutures. As illustrated, thenotch 1075 has a radius of approximately 0.5 mm in a vertical direction,and a radius of approximately 0.2 mm in a horizontal direction.Preferably, the handle 1072 has a length of approximately 100 mm.

The main body 1074 comprises a generally spherical mass, having a nearlysemi-annular recess 1078 extending about an axis of the main body 1074which is generally perpendicular to the longitudinal axis of handle1072. The diameter of the main body 1074 is approximately 15.7 mm. Otherconfigurations will also become apparent to one of skill in the art inview of the present disclosure.

In the illustrated embodiment and as discussed above, the annular recess1078 extends into the main body 1074 to a minimum depth of about 0.2 mmto 3.0 mm, and has a radius of approximately 0.5 mm. These dimensionshave been found suitable for holding the first throw of the knot whilemaintaining suture tension, when tying down the sutures typicallyutilized in the bladder suspension procedure, which typically have adiameter of about 0.5 mm.

As will be apparent to one of skill in the art in view of the foregoingdisclosure, any of a wide variety of modifications can be made to thebasic dimensions recited herein, and still permit accruing theadvantages of this aspect of the present invention.

The operation of the tensioner 1070 is similar to that described above,and therefore will not be reiterated here.

IV. VAGINAL/ABDOMINAL DRAPE AND EXPOSURE SYSTEM

In accordance with another aspect of the present invention, there isprovided a drape and exposure system comprising a vaginal drape,speculum and buttock plate adapted for isolating the surgical field,providing a mounting surface for surgical instruments, and opening thesurgical area for access. More particularly, the drape, speculum andplate are particularly suited for use in connection with pubo-vaginalsurgery such as a bladder suspension procedure.

The drape and speculum protect the surgical area to reduce the risk ofcontamination, especially from the anal area. The speculum additionallyprotects the posterior internal structures of the patient from needle orother damage. The buttock plate provides a mounting surface for thespeculum and other surgical instruments. These and other features andadvantages will become apparent as discussed below.

Referring to FIGS. 24-29, there is disclosed the vaginal/abdominal drapeand exposure system of the present invention. In general, the drape andexposure system comprises a vaginal drape 302, vaginal speculum 304, andbuttock plate 306.

The vaginal drape 302, as illustrated in FIGS. 24 and 25 generallycomprises an abdominal drape 308, a surgical window 310, a moisturebarrier 320, and a vaginal flap 330. The abdominal drape 302 is a large,flexible, sterilizable membrane which is about 2400 mm wide and 1000 mmtall. Other dimensions may be used as will be apparent to one of skillin the art. A number of cable ties 315 are provided on the back of thedrape 302. As illustrated the ties 315 are rectangular projectionshaving holes for acceptance of cables and tubes from ancillary surgicalequipment. Alternatively the ties 315 could have a velcro surface forquick and easy attachment to a corresponding pad (not shown).

The surgical window 310 comprises a generally rectangular transparentmembrane. The surgical window 310 is located in the abdominal drape 308approximately equidistant from the lateral sides and at a distance ofabout 760 mm from the top edge. The surgical window 310, as illustrated,is 120 mm wide and 120 mm inches high, having the bottom 50 mm taperedinward at 45 degrees so that the base is only 100 mm wide. The window310 may, however, be of any size or dimension depending on theparticular procedure engaged in, as well as the size of the particularpatient being operated on. The dimensions of the illustrated embodimentare particularly well suited for use in a bladder suspension procedures.

The surgical window 310 is preferably made from a transparent plasticwhich is flexible, and yet resistant to bacterial penetration andtearing. The surgical window 310 has an adhesive backing 312. Before thevaginal drape 302, and thus the surgical window 310 are installed foruse, adhesive backing 312 is preferably covered with a protective sheet314 which prevents the adhesive backing 312 from adhering to undesireditems. Protective sheet 314 is preferably precut so it may be easilypeeled laterally away in two or more strips approximately 120 mm wide toexpose the adhesive backing 312.

An alignment opening 317 is provided just below the surgical window 310in the moisture barrier 320. The alignment opening 317 is 50 mm by 50 mmto allow the passage of a sterile glove covered hand through it so thatthe user may palpate the pubic bone and guide the drape 300 into itsproper position.

When installed for use, the surgical window 310 is placed over thesurgical incision site. The adhesive backing 312 is exposed by removingthe protective sheet 314. The surgical window 310 is then adhered to thearea of the incision site. Alternatively, the surgical window 310 maysimply be an opening in the drape, devoid of any material.

As illustrated, the moisture barrier 320 is attached to the lower centerportion of the abdominal drape 308. The moisture barrier 320 is, asillustrated, rectangular in shape, preferably being about 600 mm widewhere it connects with the drape 308. The barrier 320 is approximately900 mm long. Once again, these dimensions are variable depending on thesize of the particular patient and the particular procedure beingperformed.

Preferably, the moisture barrier 320 is made from a material which isflexible and sterilizable, such as vinyl or polyethylene, available fromDow Chemical, or other suitable surgical drape material.

A buttock plate pocket 322 extends from about the center of the moisturebarrier 320. The pocket 322 extends along the width of the barrier 320and is preferably about 26 cm deep, being closed on its sides, back, andtop. The pocket 322 allows the sterile placement of the buttock plate306 under the patient.

The vaginal flap 330 is mounted in the moisture barrier 320 in an areanear the surgical window 310. The vaginal flap 330 as illustrated inFIG. 25 is generally flat in shape, having a speculum pocket 332 at itssuperior end. The flap 330 is loosely connected to the moisture barrier320 along the lateral edges of the flap with easily torn serrations.Alternatively, the flap 330 may be made of an elastic material, with orwithout a speculum pocket 332, which allows the vaginal speculum 304 andstretched flap 330 to easily be placed into the vagina, providing apositive barrier against anal contamination. As an additionalalternative, the vaginal flap 330 may simply be an opening in the drape,devoid of any material.

The vaginal flap 330 is approximately 110 mm long and has a width ofapproximately 50 mm. The vaginal flap 330 is preferably formed as partof the moisture barrier 320 and thus is made of the same material as themoisture barrier. The speculum pocket 332 is generally flat with an openend 333 at its connection with the vaginal flap 330 extending to aclosed end 334.

Adhesive backing strips 321 are located on the rear side of the moisturebarrier 320 adjacent either side of the vaginal flap 330. The adhesivestrips 321 are preferably approximately 50 mm wide and covered withprotective sheets. Additionally, another adhesive strip 325 covered witha protective sheet 326 during non-use, is located just below the vaginalflap 330. This strip 325 is approximately 25 mm wide and extends 75 mmto either side of the centerline of the vaginal flap 330.

The buttock plate 306 is illustrated in FIGS. 26 and 29. The plate 306comprises mainly a flat, rectangular support surface 350, and anupwardly extending mounting arm 352.

In the illustrated embodiment, the support surface 350 of the plate 306is about 220 mm wide and nearly 180 mm long. The support surface 350 hasa thickness of about 3 mm, although this and other dimensions dictatedprimarily by desired structural integrity may be varied depending uponthe construction material. At one end the support surface 350 is taperedat about a 45 degree angle. The upwardly extending mounting arm 352 islocated opposite the tapered end of the support surface 350.

The upwardly extending mounting arm 352 of the plate 306, asillustrated, is part of the support surface 350, however it iscontemplated that the upwardly extending mounting arm 352 could be aseparate member which is connected to the support surface 350. Theupwardly extending mounting arm 352 is approximately 50 mm tall and 50mm wide.

The upwardly extending mounting arm 352 has a bore 354 located in italong the centerline axis of the width of the plate 306 and at a heightof 40 mm above the bottom of the support surface 350. This bore 354 ispreferably threaded and has a diameter of about 0.250 inches.

It is preferred that the entire buttock plate 306 be made from amaterial, such as stainless steel, which is sterilizable and relativelyrigid.

Referring to FIGS. 27-29, there is shown the vaginal speculum 304 of thepresent invention. The vaginal speculum 304 generally comprises anelongated concave member 360 and a support stem 362. The concave member360 is a semi-circular plate approximately 110 mm long. The member 360has a semi-circular cross section which would be 90 mm in diameter atits proximal and distal ends if the member formed a complete circle.However, the member 360 forms only a partial circle, extending such thatits proximal end width is 45 mm and its distal end width is 38 mm. Thesedimensions are fairly typical of those that will provide a speculum 304which may be used on most patients. However, due to variation in patientsize, etc., it is contemplated that these dimensions may be readilychanged to accommodate such variations.

The support stem 362 is mounted to the proximal end of the concavemember 360. The support stem 362, as illustrated, is molded as part ofthe concave member 360, although it is contemplated that the supportstem could be a separate piece which is later attached to the concavemember.

The support stem 362 is about 150 mm in height from the highest point onthe concave member 360 to the bottom of the stem 362. The stem 362 isapproximately 5 mm thick, and after extending down from its connectionwith the concave member is approximately 40 mm wide. The stem 362 isconnected to the concave member 360 such that the concave memberinclines downward and inward towards the plate 306 at an angle of 25degrees from a perpendicular to the stem 362. While the concave member360 may extend uniformly down from the stem 362 at a 25° angle, themember 360 may also be nearly perpendicular to the stem 362 and thenbecome arcuate in shape until it slopes at approximately a 25° anglefrom the horizontal.

While the stem 362 may be 5 mm thick, a thinner stem is allowable aslong as its rigidity and strength are not compromised. Further, whilethe concave member 360 may be thick in order to retain rigidity, athinner member allows the vaginal opening space to be maximized. Lastly,if the concave member 360 meets the stem 263 nearly horizontal and witha low profile, the ease of entry and exit into the vagina is maximized.

A slot 364 is provided in the stem 362 a short distance from its base,and extends 100 mm upwardly along the center axis of the stem. Slot 364is about 7 mm in width. A knurled knob 366 is provided for extensionthrough the slot 364. Knob 366 has a stem which is threaded, has anouter diameter of 0.25 inches, and is approximately 20 mm long.

It is preferred that the speculum 304 may be made from a material, suchas stainless steel or aluminum, which is sterilizable and sufficientlyrigid for its intended purpose.

An alternate preferred embodiment buttock plate 906 is illustrated inFIGS. 50-54. The plate 906 is similar to that described above, beingmainly a flat surface 950, and includes an upwardly extending mountingarm 952, however in this embodiment the surface 950 is somewhatcircular.

In the illustrated embodiment, the support surface 950 of the plate 906is about 127 mm wide and nearly 127 mm long, although this and otherdimensions are, as discussed above, dictated primarily by desiredstructural integrity may be varied depending upon the constructionmaterial. As stated above, it is desired, however, that the plate 906 besomewhat circular, and therefore has broadly rounded corners. Theupwardly extending mounting arm 952 is located on a somewhat straightside of the support surface 950.

The upwardly extending mounting arm 952 of the plate 906, asillustrated, is part of the support surface 950, however it iscontemplated that the upwardly extending mounting arm 952 could be aseparate member which is connected to the support surface 950. Theupwardly extending mounting arm 952 is approximately 51 mm tall and 51mm wide and has rounded, smooth corners.

The upwardly extending mounting arm 952 has a bore 954 located in italong the centerline axis of the width of the plate 906 and at a heightof 38 mm above the bottom of the support surface 950. This bore 954 ispreferably threaded and has a diameter of about 0.75 inches.

It is preferred that the entire buttock plate 906 be disposable, andtherefore be made of a thermoplastic material by molding or the like. Inparticular, the thermoplastic Cycolac 2679F made by General ElectricPlastics has been found suitable, which is Acrylonitrile ButadieneStyrene (ABS). In order that the plate 906 be rigid and strong whenmanufactured from a thermoplastic, a support rib 953 may connect themounting arm 952 and the surface 950. Additionally, to insure thatsurface 950 remains flat, a number of ribs and recess may be formed intothe bottom of the surface 950 as illustrated in FIGS. 54 and 54a duringmolding. If not disposable, the plate 906 may be manufactured fromstainless steel or other sterilizable and relatively rigid material maybe used.

Referring to FIGS. 50 and 55-59, there is shown an alternate preferredembodiment vaginal speculum 904 of the present invention, mostpreferably used in conjunction with the buttock plate 806 describedabove. The vaginal speculum 904 generally comprises an elongated concavemember 960 and a support stem 962. The concave member 960 is asemi-circular plate approximately 130 mm long. The dimensions of themember 960 are similar to those for the member 360 described above, andsuch are incorporated by reference here.

The support stem 962 is again mounted to the proximal end of the concavemember 960. The support stem 962, as illustrated, is molded as part ofthe concave member 960, although it is contemplated that the supportstem could be a separate piece which is later attached to the concavemember.

The support stem 962 is preferably about 140 mm in height from thehighest point on the concave member 960 to the bottom of the stem 962.The stem 962 is approximately 51 mm wide. The stem 962 is againconnected to the concave member 960 such that the concave memberinclines downward and inward towards the plate 906. Once again, it isnoted that while the concave member 960 may extend uniformly down fromthe stem 962 at a uniform angle, the member 960 may also be nearlyperpendicular to the stem 962 and then become arcuate in shape.

Preferably, the stem 962 has raised or ridged sides located about acenter slot 964, which is described in more detail below. The ridgedsides of the stem 962 provide added rigidity to the member, allowing itto be thinner between the sides. Thus, while the stem 962 illustrated isapproximately 7 mm thick, a thinner stem is allowable as long as itsrigidity and strength are not compromised. Further, while the concavemember 960 may be thick in order to retain rigidity, a thinner memberallows the vaginal opening space to be maximized. Lastly, if the concavemember 960 meets the stem 963 nearly horizontal and with a low profile,the ease of entry and exit into the vagina is maximized.

Slot 964 is provided in the stem 962 a short distance from its base, andextends 102 mm upwardly along the center axis of the stem. Slot 964 isabout 19 mm in width. As illustrated in FIG. 50, a knob 966 is providedfor extension through the slot 964. The knob 966 preferably comprises anelongated body 967 for engaging ramps (not shown) on the stem 962 of thespeculum 904 along a sufficiently long distance to clamp the stem 962against the buttock plate to prevent any movement, such as pivoting, ofthe speculum 904 with respect to the plate 906, when the two are engagedas in FIG. 52. The knob 966 also includes a long stem which passesthrough the body 967, which stem can be rotated to cause locking of theknob 966 against the ramps. The stem preferably has an outer diameter of19 mm, and is approximately 25 mm long.

It is preferred that the speculum 904 be disposable and therefore ismade from a thermoplastic material. In particular, the thermoplasticCycolac 2679F made by General Electric Plastics has been found suitable,which is Acrylonitrile Butadiene Styrene (ABS). If not to be disposable,stainless steel or aluminum may be used.

The use of the vaginal drape 302, vaginal speculum 304, 904 and buttockplate 306, 906 will now be described as used in a bladder suspensionprocedure in conjunction with FIGS. 24-29.

When the patient is placed in the lithotomy position and sterilelyprepared for the procedure, the sterile drape 300 is opened to exposethe opening 317. The surgeon's fingers are inserted through the opening317 and placed onto the area of the interior portion of the vaginalintroitus. The drape 300 is then guided over the fingers and into place.At this time the surgical window 310 is aligned over the surgical area,and the protective sheet (not shown) covering the adhesive backing 312is removed. The surgical window 310 is then pressed against the patientto adhere it securely over the surgical area. The moisture barrier 320is then attached via the adhesive 321 and 325 to the patient's skin.

The remaining portion of the vaginal drape 302 is then pulled downwardbetween the legs of the patient securely. The buttock plate 306 isinstalled in the buttock pocket 322 with the flat support surface 350laying flat on the table under the patient. The upwardly extendingmounting arm 352 of the plate is located between the patient's legs.

As is evident, the adhesive backing 312 both secures the window 310 overthe surgical site, as well as secures this end of the vaginal drape 302to the patient so as to create a tight barrier from the buttock plate306 to the surgical area.

Preferably, flap 330 is stretchably increased in size with thepositioning of the speculum 304 into the vagina. Alternatively, thedistal end of the speculum 304 is placed in the speculum pocket 333 ofthe drape 302. The speculum 304 and pocket 322 are then inserted intothe vagina of the patient. Once in place, the speculum 304 is attachedto the buttock plate 306. Referring to FIG. 29, the slot 364 in the stem362 of the speculum 304 is located over the threaded hole 356 on theupwardly extending mounting arm 352 of the buttock plate 306. Thespeculum 304 is adjusted by sliding the slot 364 vertically untilproperly adjusted. The knob 366 is then threaded into the hole 354 andtightened to lock the speculum 304 to the plate 306. Additionally othersurgical instruments may be mounted to the mounting arm 352 such astissue retractors, clamps, etc. Alternately, the speculum 304 may beclamped in a flexible mount to allow for small movements of the patientrelative to the buttock plate 306, and to provide for adjustments to theangle and orientation of the speculum 304. This may be accomplished by,for example, locating a slotted rubber hemispheres or other flexiblestructures (not shown) on the stem of the knob 366 on either side of thespeculum stem.

V. SUTURE SUPPORT

In accordance with yet another aspect of the present invention, there isprovided a suture support which is used to anchor sutures with respectto soft tissue inside the body. The suture support reduces the trauma tointernal body tissue which can occur when a suture is tied off solely intissue, by increasing the tissue area which supports the forces exertedby the suture. In the context of a bladder neck suspension procedure,the suture support is intended to keep a suture from pulling though thevaginal wall tissue.

As illustrated in FIG. 30, there is shown one embodiment of the suturesupport 450. This suture support 450 comprising a support plate 452 anda suture tab 454. The plate 452 is about 15 mm in diameter and it ispreferred that the thickness of the support 450 not be greater than thediameter of the suture, or about 1 mm. It is contemplated that the plate452 be made in any variety of shapes, the shape dictated primarily bythe location in which the suture support 450 is to be placed. The plate452 is preferably made from plastic, stainless steel, or a poly coatedstainless steel, so as to be biocompatible and sterilizable.

The suture tab 454 is a small loop connected to the plate 452 foraccepting sutures. The tab 454 is preferably molded or punched as partof plate 452, however, the tab 454 could be made separately and attachedto the plate 454 as would be apparent to one skilled in the art.

Referring to FIG. 31, there is shown an alternate embodiment of thesuture support 450. This support 450 comprises a lattice 456 or meshframework. Mesh type suture supports may be preferred since the tissuecontact area is minimized for a given load distribution are compared toa solid plate type embodiment. This can facilitate tissue ingrowth, andtends to minimize localized necrosis beneath the support.

The lattice 456 is preferably constructed from plastic, such aspolypropylene, or stainless steel wire having a diameter of about 1 mm.The illustrated lattice 456 has a circular outer edge, with a diameterof about 15 mm. The lattice 456 could be made into the form of a square(See FIG. 32) or any other shape, depending upon the use of the suturesupport 450. In the illustrated embodiment, the lattice 456 itselfprovides a suitable tie off for sutures, and thus no other sutureconnector would be needed. The suture can be premolded into the lattice456.

Referring to FIG. 33, there is shown yet another embodiment of thesuture support 450 of the present invention. This support 450 comprisesan outer ring 458 (although the support can, of course, be square orovoidal as shown in FIG. 34) and inner spokes 460. The outer ring 458 isa washer like member which rests against the tissue in order to supportthe suture. The ring 458 has an outer diameter of about 15 mm, and aninner diameter of about 13 mm. The ring 458 may, of course, be made inother shapes, such as a square or ovoidal, and may have a wider orthinner support surface depending upon the particular use of the support450. The ring 458 is about 2 mm thick and is preferably made frompolypropylene or stainless steel.

A number of spokes 460 radiate from the inner portion of the ring 458 toits center. As illustrated, four spokes 460 each 2 mm in diameterconnect to one another and the ring 458. The center of the ring 458where the spokes 460 meet, is used for attaching sutures.

It is possible that in the above embodiment of the suture support, thatthere only be spokes 460 and no ring 458. In this case, the suture isagain tied off to a center convergence point for spokes 460, and thesupport for the suture is provided merely by the spokes, as no outerring is present. In this form the suture support 450 allows for morerapid tissue ingrowth.

In the context of a bladder neck suspension procedure, the suturesupport can effectively be used in two ways. Placement of a suturesupport 450 may be made merely by pulling the suture and support upwardagainst the tissue, such as the vaginal wall, snugly. It is alsopermissible for a small incision to be made in the vaginal mucosa, thuscreating a mucosal flap, beneath which the suture support may be placedand then closed. Lastly, it is contemplated that more than one suture beused in conjunction with any of the above embodiments of the suturesupport 450. Further, it is contemplated that one end of a suture may beintegrally molded with any of the above embodiments constructed ofplastic.

VI. STAPLE APPLIER AND TISSUE STAPLES

In accordance with a further aspect of the present invention, there isprovided a variety of tissue staples and a staple applier. The staplesare an alternative to sutures and are used to connect and supporttissue. In particular, the staples may be used in a transvaginal bladdersuspension procedure for supporting tissue from the iliopectinealligament or other suitable nearby ligamentous tissue or bone.

Referring to FIG. 35, there is disclosed a tissue staple 500 for use inthe bladder neck suspension procedure of this aspect of the presentinvention. The staple 500 is in the form of a partial ellipse having theapproximate dimensions of 10 mm along the longitudinal axis and 7 mmalong the short axis. However, the precise dimensions of the staple 500may be varied to suit particular applications, and to provide for asuitable gap between the supporting tissue and the iliopectinealligament, as will be apparent to one of skill in the art.

The lateral ends 504 of the staple 500 are preferably sharpened toprovide easy penetration of tissue. The staples 500 are preferablystamped from a material such as stainless steel, titanium or othersheeting, with or without an outer polymeric coating, or molded orformed from a material which is biocompatible, sterilizable and whichwill exhibit relatively long term integrity. Alternatively, staple 500may be formed from wire or ribbon stock, such as 0.25 mm diameter springwire. The staples may, of course, have an enlarged center portion suchas staple 501 in FIG. 36 in order to distribute the forces about alarger area of tissue. The enlarged area preferably has one or moreopenings to allow ingrowth of tissue.

The staple applier 502, as illustrated in FIGS. 37-39, comprises ascissor like body 510 having an opposing pair of pressing supportmembers 512, and preferably the body 510 is also provided with a pair ofreleasing prongs 514. The body 510 comprises two arms 516 and twohandles 518. The arms 516 may be constructed in any of a variety ofdimensions, and, in one embodiment, are about 160 mm in length and 4 mmin diameter. In one embodiment, the upper arm 516 has a small flange 517on its distal end, as well as a hole 513 extending through the flangeand along the arm to a point proximal of the flange, to allow thepassage of a support member 512, as will be discussed below. The arms516 are pivotally connected about a pin 520 or other conventionalfastener which passes through bores in the flange 517 in the upper armand through the distal end of the other arm.

Handles 518 are disposed on the proximal end of each arm 516. Thehandles 518 are slightly elliptically shaped loops which are sized tofacilitate the introduction of a fingers for manipulation of thehandles. Preferably, handles 518 are formed with a loop in the proximalextension of the corresponding arm 516.

A support member 512 is mounted on the distal end of each of the arms516. The support members 512 generally are mounted perpendicular to thelongitudinal axis of the body 510, being generally concave toward eachother, curving first laterally from their point of attachment with thearms 516, and then medially as will be understood from the intendedfunction. The support members 512 are connected such that the proximalof the two members extends upwards from its connection with the lowerarm through the hole 513 in the upper arm. In this manner, the proximalmember is allowed to move with respect to the distal member. The supportmembers 512 are thin curved members having a width of about 6 mm attheir base which connects with the arms 516. Preferably, the remainderof the members 512 have widths corresponding with the width of thestaples 500, and thus taper to a width of about 3 mm near their distalends. The distal ends of the support members 512 are thus narrow, thin,and concave to match the curve of the staple 500, providing guidance soas to allow easy entry and closure of the staple 500 into tissue. Thesupport members 512 should be shaped, however, so that when the arms 516are open, the distal ends of the members 512 are approximately 15 mmfrom one another, thus leaving a gap between them for entry about asection of tissue. The exact radius of curvature of each of the members512 should be such that they nearly mirror the shape of the staples 500.

Preferably, to permit removal or widening of the radius of an installedstaple, an opposing pair of staple removal prongs 514 are mounted one oneach member 512. The prongs 514 are solid shafts which may be generallyU shaped, and comprise a component which extends generally perpendicularto both the longitudinal axis of the body 510 and the members 512. Theprongs 514 thus have one end which is attached to one of the members512, and one end which is exposed and is located a distance from themember 512. In this manner, the opposing staple removal prongs 514 areadvanced towards each other and drawn apart from each other by relativemanipulation of the arms 516 about pivot 520.

It is preferred that the entire staple applier 502 be made from amaterial which is relatively biocompatible, and sterilizable, as is wellknown in the surgical instrument art. The applier 502 must also be madefrom a material which is sufficiently rigid to accomplish the intendedpurpose, such as stainless steel.

The operation of the staple applier 502 will now be described inconnection with FIGS. 37 and 38. The arms 516 are first distanced fromone another, so that the support members 512 are also apart. A staple500 is inserted in between the members 512 and prongs 514. The stapleapplier 502 is inserted into or against the portion of the body wherethe staple 500 is to be used. The ends 504 of the staple 500 and thedistal ends of the support members 512 are pressed into the tissue inthe area to be stapled. It can now be seen that because the supportmembers 512 are mounted 90 degrees to the arms 516, the staple 500 maybe applied in areas, such as the vagina, where the tissue to be stapledis located approximately perpendicular to the axis of the arms 516.

Once the staple 500 has been pressed into the tissue a sufficientdistance, the staple 500 is closed by compressing the handles 518, andthus the arms 516 and members 512, together to engage the internalsupport structure. When this occurs, the members 512 push upon thestaple 500 so as to press the free ends of the staple 500 together, thuslocking material, such as tissue, inside the staple 500.

If it is necessary to remove a staple 500 from tissue or other material,the prongs 514 are used. The applier 502 is located such that the placedstaple 500 is in between the members 512 and prongs 514. The handles518, and thus the arms 516 are pulled apart. This causes the prongs 514to move apart and pull on each side of the staple 500, causing it toexpand as its free ends separate.

Alternatively, the staples 500 may be shaped so as to have straightrigid parallel lateral ends that allow the staple to be driven straightinto a bone, such as the pubic bone, as would be apparent to one skilledin the art. In a further variation, a single nail-like attachment device(not shown) may be used to affix any of the suture supports 450described in Section V. above. When using these staples 500, a slaphammer, or power driven device such as that commonly used in orthopedicsand well known to those skilled in the art, may be used to place thestaple, and a suitable gap between the staple and the bone is providedby the staple applier 502 so as not to crush the tissue between the boneand the staple.

Alternatively, the staples 500 may be preformed of a suitable springmaterial such as Nitinol in approximately the final relaxed and desiredshape of a closed oval, as would be apparent to one skilled in the art.In this mode, the staple applier 502 is used to hold the staple 500between the prongs 514 in an open state with the sharpened ends of thestaple separated to allow passage through the layers of tissue. When thestaple 500 is in the desired location, the handles 518 are allowed toopen, which in turn allows the staple to close into its final desiredshape, thus capturing and locking the desired tissue.

VII. "C" CLAMP

In accordance with another aspect of the present invention, there isprovided a "C" clamp for locating and aligning a drill bit. The "C"clamp is an alternative to the drill guide of the present invention, andis designed for use with the buttock plate. The "C" clamp has a drillguide which aids in locating a drill bit through the pubic region andinto the vaginal area.

Referring to FIG. 40, there is disclosed a "C" clamp 600 for use in thebladder neck suspension procedure of the present invention. The "C"clamp 600 generally comprises a support arm 602, attachment member 604,and guide arm 606.

The attachment member 604 is a generally rectangular plate or armpreferably having a slot 608 extending axially therethrough to permitadjustment as will become apparent. The member 604 in one embodiment isabout 40 mm in width, 5 mm in thickness, and about 10 mm in length. Theslot 608 is approximately 100 mm long and at least 7 mm in width, sothat a bolt connected to the knob 366 which fits into the buttock plate306 bore 354 will pass through the slot 608.

The support arm 602 is mounted to the attachment member 604. The supportarm 602 is generally L shaped, having one end which attaches to theattachment member 604, a bore 610 for acceptance of the guide arm 606,and a distal end 612 which has a drill stop 614 thereon.

The support arm 602 is about 6 mm in diameter along most of its length,except where the bore 610 is located, where the arm 602 becomes flat,being about 40 mm wide and 5 mm thick. The support arm 602 extendsoutward to the drill stop 614 a distance of about 60 mm, so that whenthe support arm 602 is in place, the drill stop 614 is inside the vaginaand the attachment member 604 and bore 610 are outside of the body. Inone embodiment, the drill stop 614 located on the distal end 612 of thearm 602 is shaped like a half sphere, being about the same diameter asthe arm 602.

The guide arm 606 is also somewhat L shaped, having a threaded shaft 616on one side, and a drill guide 620 on the other. The shaft 616 has adiameter of about 8 mm and is about 80 mm in length. The shaft 616 isthreaded along about 60 mm of its length from a distal end 618 of theshaft towards its connection with the drill guide 620. Threaded knobs626 having an inner diameter corresponding to the outer diameter of theshaft 616 are provided for axially adjustably securing the guide arm 606to the support arm 602, thus forming the "C" of the "C" clamp. A pin 633is inserted through a hole in the attachment member 604 and into acorresponding slot in the shaft 616 so as to prevent rotation of the arm606 relative to the support arm 602.

The drill guide 620 extends from the shaft 616 nearly perpendicular tothe axis of the shaft 616. The drill guide 620 extends from a narrowneck 622 which is also about 8 mm in diameter, to a rectangular block626 which is about 25 mm in thickness. A drill guide bore 624 passesthrough block 626, and is preferably about 4 mm in diameter so as toallow the passage of a drill bit.

A bone probe 630 is preferably axially movably extendable through a bore632. Bore 632 is preferably located about 5 mm from the drill guide bore624 on the side of the guide arm 606 farthest from the shaft 616. Thebore 632 is substantially parallel to the bore 610 so that the boneprobe 630 may be used to aid in locating the bone through which the holeis to be drilled, as well as aids in temporarily anchoring the guide 620to the bone. Alternatively, the bone probe 630 may be inserted throughthe drill guide bore 624 to verify the bone location.

A second bone probe (not shown) may be provided for extension through asecond bore (not shown) located on the other side of the drill guidebore 624. In this manner, two bone probes may be used to locate the bonein a fashion similar to the drill guides 10, 210 described above andshown in FIGS. 1-4 and 19-20.

The length of the drill guide 620 and orientation of the bore 624 arepreferably such that when the shaft 616 is inserted into the bore 610 inthe support member 606, a drill bit passing through the bore 624 in theblock 626 will encounter the drill stop 614 on the support arm 602.

In operation, the distal end 612 of the "C" clamp 600 is inserted intothe vagina of the patient and the drill stop 614 is placed alongside thebladder neck. At this time the guide arm 606 will either be extendedfully, or will be removed from the "C" clamp 600 altogether. The slot608 in the attachment member 604 is then aligned with the bore 354 inthe buttock plate 306 and the threaded shaft on knob 366 is passedthrough the slot 608 and into the bore, at which time the support arm602 is secured into place.

The guide arm 606 is then inserted into the bore 610 in the support arm602, or if already in place, lowered down. The guide arm 606 is securelystationed by tightening the knobs 626 on the threaded shaft 616 untilthe drill guide 620 portion of the guide arm 606 is snugly against thepatient. The bone probe 630 is then extended into the tissue until itcontacts the bone. The bone probe 630 may also, as described above, beinserted into the drill guide bore 624 to verify the bone location. Adrill bit may then be inserted into the bore 624 so as to drill a borethrough the pubic bone and into the vaginal area, where the drill stop614 will prevent the bit from further travel.

When the drill bit is removed, the bone probe 630 aids, along with theattachment to the buttock plate 306, in securely stationing the "C"clamp 600 so that it does not move. In this manner, the hole which wasdrilled through the tissue and bone is easily locatable by the surgeonwhen the drill bit has been removed. In this manner, implements such asa hooked probe may be used to facilitate the passage of sutures and orbone anchors through the hole.

EXAMPLE I

A. Patient History

The records of 30 women with SUI who were treated with modifiedendoscopic bladder neck suspensions consecutively by the author werereviewed. Twenty-eight patients underwent modified endoscopic bladderneck suspensions alone, while two patients had modified endoscopicbladder neck suspensions with concomitant vaginal procedures such asrectocele and/or cystocele repairs. The patients' ages ranged from 38 to74. The grading of SUI, based on the Stamey system², was grade 1 in 13patients and grade 2 in 17 patients. There were no grade 3 patients.Patients had a median of 2 vaginal deliveries. Fifty-seven percent ofpatients had had a previous hysterectomy. Twenty percent of patients hadhad at least one previous surgical procedure to correct urinaryincontinence.

All patients had a history demonstrating bothersome urinary leakage withactivities and physical examination demonstrating a hypermobile urethraand pliable pubocervical fascia. Complaints preoperatively includedurgency in 63% and urgency incontinence in 40% of patients. Preoperativetesting in all patients included 1) a Marshall test that demonstratedleakage with coughing and one finger control of leakage with bladderneck elevation and 2) a cystometrogram that did not demonstrateuninhibited contractions.

B. Technique

All patients received gentamicin and ampicillin preoperatively unless anallergy existed. Anesthesia was regional in 16 patients and general in14 patients. A surgical assistant was not used. The patients were placedin the lithotomy position. Preparation emphasized isolation of the anuswith a stapled towel or plastic drape. A Foley catheter was passed.

Two separated, one inch transverse incisions were made over the pubicbone (FIG. 8) and dissection was carried down to the area of the rectusfascia. Beginning on the right side, the wound was stretched cephalad toallow the vertical passage of a Stamey needle (Pilling Company, FortWashington, Pa.) through the rectus fascia (FIG. 9A). The needle wasthen sharply angled onto the abdomen so that the point rested on theunderside of the pubic periosteum (FIG. 9B).

The point of the needle, while maintaining contact with the underside ofthe pubis, was thereafter passed distally toward the introitus. At thecompletion of this distal passage, the needle could be palpated throughthe introitus to the right of the urethra (FIG. 9C). Palpation throughthe vagina was avoided during this distal passage of the needle to avoidpushing the bladder or urethra into the path of the needle. The tip ofthe needle was withdrawn from the pubourethral ligament and gently sweptalong the pubocervical fascia to the area of the bladder neck (FIG. 9D)under the guidance of a finger within the vagina.

The needle was then passed through the pubocervical fascia and vaginalmucosa at point 1 (FIG. 10A). A number 1 polypropylene suture was passedthrough the needle hole and withdrawn with the needle through the pubicwound (FIG. 10B). The needle was then reintroduced through the rectusfascia 2 cm. lateral to the initial passage and through the vaginalmucosa at point 2 (FIG. 10C) using the same needle passage techniquedescribed above (FIG. 9A-D). The tip of the needle with the vaginal endof the suture was then withdrawn into the retropubic space (FIG. 10D)and then advanced to point 3 where it was passed through the vaginalmucosa and passed distal to the introitus (FIG. 10E).

The suture was then removed from the needle and the needle tip was onceagain withdrawn to the retropubic space (FIG. 10F) and passed throughthe vaginal mucosa at point 4 (FIG. 10G). The vaginal end of the suturewas then passed into the needle and pulled up through the pubic woundusing the needle (FIG. 10H). An attempt was made with the 4 entry pointsthrough the pubocervical fascia to maximize 1) their separation(approximately 2 cm. apart), and 2) their laterialization from thebladder neck and urethra (approximately 2 cm. away) (FIG. 13A).

The identical procedure was performed on the left side. Direct or videocystoscopic confirmation of suture position was performed on the leftside. Direct or video cystoscopic confirmation of suture position wasperformed with special attention to avoid handling the contaminatedeyepiece of the cystoscope (when video cystoscopy was not done).

The Mitek Anchor System (Mitek Surgical Products, Inc., Northwood,Mass.) was then used in all patients for pubic bone fixation of thesuspensory sutures. Mitek G1 anchors (FIG. 11A) were used in the firstseven patients and the newer Mitek G2 anchors (FIG. 11B) were used inthe remaining 23 patients. Two holes were drilled into the pubic boneapproximately 2 cm. lateral to the symphysis (FIG. 12A). One anchor foreach side (2 per patient) was loaded with a medial suture end (which hadhad less vaginal contact than the lateral ends, thereby, potentiallyreducing the chance of bacterial contamination). Each anchor was placedinto its hole using an inserter (FIG. 12B). The inserter was extractedleaving each anchor in place (FIG. 12C). Traction was placed on thesutures to assure adequate fixation of the anchors.

The sutures on each side were then tied down with sufficient tension soas to develop a gentle elevation and cradle-like support of the bladderneck (FIG. 13A and 13B). A modification to limit and control the tensionon the suspending suture web in a reproducible manner was instituted inthe last 17 patients within the study. The sutures in these patientswere tied down snugly on the distal pulp of the index finger (FIG. 14).

The wounds were irrigated with a bacitracin solution. The wound edgesand the rectus fascia at the suture entry points were infiltrated withbupivacaine. A Foley catheter was placed in 80% of the patients. Theremaining patients had a suprapubic tube placed because of the dexterityproblems or their aversion to learning intermittent catheterization.

Following surgery, patients were given either ciprofloxacin or ofloxacinfor 10 days. The patients' Foley catheters were removed one weekfollowing surgery. The patients performed intermittent catheterizationas necessary until the post-void residuals were less than 75 cc. on twoconsecutive catheterization. Patients with suprapubic tubes generallybegan voiding trials at 4 days following surgery. The suprapubic tubeswere removed when the post-void residuals were less than 75 cc.following two consecutive urinations.

C. Results

All 30 women who underwent this procedure were evaluated within thefirst month post-operatively ("post-op" follow-up). The initial 16consecutive patients of this group were evaluated up to eight monthsafter surgery by mail questionnaires ("short-term" follow-up). Threepatients who did not return their questionnaires were contacted byphone. The procedure was performed on an outpatient basis in 12 of thelast 17 patients with the suture tension limiting technique (71%)compared to 2 of the first 13 patients without the technique (15%) (FIG.15). Many patients did not require narcotic analgesics followingdischarge. Seventy-three percent of patients did not requireintermittent catheterization beyond the day that their indwellingcatheter was removed (FIG. 16). All patients became catheter free. Theprevalence of urinary urgency was similar at the post-op and short termfollow-ups at 17 and 19 percent, respective (FIG. 17). Six percent ofpatients complained of urgency incontinence on short term follow-up.Twenty-nine of 30 patients (97%) had cure of stress incontinence onfollow-up; all 30 patients on post-op follow-up and 15 of 16 (94%) onshort-term follow-up. Cure was defined as the lack of urinary leakagewith activity. One woman developed urinary leakage three monthsfollowing her surgery. She had the first set of G1 anchors placed andalso had the suspending suture tied without the technique of tensionlimitation. That patient's anchors appeared to be within the pubic boneon an anterior-posterior view of the pelvis. FIG. 18 indicates thepatients' satisfaction with the results of their procedure as taken fromtheir short term questionnaire. There were no wound or bone infections.

EXAMPLE II

A group of patients are prepared in the manner described in Example I.Two separated, one inch transverse incisions are made over the pubicbone (FIG. 8) and dissection is carried down to the area of the rectusfascia. Beginning on the right side, the wound is stretched cephalad toallow the vertical passage of a suture passer of the type illustrated inFIGS. 5 and 6 through the rectus fascia with the probe tip fully exposed(FIG. 9A). Distal advancement of the suture passer is accomplished withthe needle (probe) tip proximally retracted within the probe guide. Thesuture passer is acutely angled into the abdomen so that the point restson the underside of the pubic periosteum (FIG. 9B).

While maintaining contact with the underside of the pubis, the suturepasser with the probe tip retracted is thereafter passed distally towardthe introitus. At the completion of this distal passage, the suturepasser can be palpated through the introitus to the right of the urethra(FIG. 9C). The distal end tip of the suture passer is withdrawn from thesurface of pubourethral ligament and gently swept along the pubocervicalfascia to the area of the bladder neck (FIG. 9D) under the guidance of afinger within the vagina. Palpation through the vagina may be safelypreformed to assist in localization of suture passer tip.

The probe tip is then distally extended. The suture passer is thenpassed through the pubocervical fascia and vaginal mucosa at point 1(FIG. 10A). The probe is then retracted maximally to the unlockedposition to allow a number 1 polypropylene suture to be manually placedinto the suture channel. The probe is moved distally to lock the suturetherein. The suture passer is thereafter withdrawn through the pubicwound (FIG. 10B) and the suture is released from the suture channel bymanually retracting the probe.

The suture passer with the probe tip extended is then reintroducedthrough the rectus fascia 2 cm. lateral to the initial passage andthrough the vaginal mucosa at point 2 (FIG. 10C) using the same passagetechnique described above (FIG. 9A-D). The vaginal end of the suture isthen placed into the open end of the suture channel and locked. Thesuture passer is then withdrawn into the retropubic space (FIG. 10D) andthen advanced to point 3 where it is passed through the vaginal mucosaas with point 1 and 2 and passed out of to the introitus (FIG. 10E).

The suture is then removed from the suture passer by maximallyretracting the probe tip to the "unlocked" position to align the suturechannel and opening in the probe guide, and the suture passer is onceagain withdrawn into the retropubic space (FIG. 10F). The probe tip isthen extended and the suture passer is pushed through the vaginal mucosaat point 4 (FIG. 10G). The vaginal end of the suture is then placed intothe unlocked suture channel and locked into place, and pulled up throughthe pubic wound. An attempt is made with the 4 entry points through thepubocervical fascia to maximize 1) their separation (approximately 2 cm.apart), and 2) their lateralization from the bladder neck and urethra(approximately 2 cm. away) (FIG. 13A).

The identical procedure is performed on the left side. Direct or videocystoscopic confirmation of suture position is performed on the leftside. Direct or video cystoscopic confirmation of suture position isperformed with special attention to avoid handling the contaminatedeyepiece of the cystoscope when video cystoscopy is done.

The Mitek G2 Anchor System (Mitek Surgical Products, Inc., Northwood,Mass.) is then used in all patients for pubic bone fixation of thesuspensory sutures. Drill sites are located by placing a drill guide 25illustrated in FIG. 1 over the pubic bone and extending the bone probesdistally until both bone probes have made contact with the pubic bone. A2.05 mm drill bit is advanced through the drill guide to produce twoholes drilled into the pubic bone approximately 2 cm. lateral to thesymphysis (FIG. 12A). One anchor for each side (2 per patient) is loadedinto the drill guide channel and advanced into its hole before removingthe drill guide after drilling. Traction is placed on the sutures toassure adequate fixation of the anchors.

The sutures on each side are then tied down with sufficient tension soas to develop a gentle elevation and cradle-like support of the bladderneck (FIG. 13A and 13B). Tension is regulated by tying the suturesacross a suture tensioner as illustrated in FIG. 7, and thereafterremoving the tensioner.

The patients are thereafter postoperatively treated as described inExample I.

EXAMPLE III

The use of a number of the above described tools will now be describedas used in conjunction with a bladder neck suspension procedure. Thefirst procedure involves suspending the bladder neck with tissuestaples. The use of the staples allow the bladder neck suspensionprocedure to be accomplished entirely intravaginally.

The patient is first prepared by placing the pubic drape 300 asdescribed above. The surgeon then properly locates the site at which thestaple 500 is to be placed with the staple applier 502. The staple 500is loaded into the applier 502 in between the support members 512. Theapplier 502 is then extended into the vagina with the handles 518 stillslightly apart. Once aligned to one side of the bladder neck, the probes512 and staple 500 are pressed through the vaginal mucosa and upwardinto the iliopectineal or other nearby ligament.

The handles 518 are then closed, pressing the support members 512together and closing the staple 500 about the ligament securely. Thehandles 518 are then opened again, spreading the support members 512apart. The applier 502 is then removed from the vagina and the foregoingprocedure is repeated on the opposite side of the bladder neck.

In this fashion, the bladder neck suspension procedure is accomplishedin a purely intravaginal procedure in which only the staple and nosuture is needed. Further, there is no need for drilling, suture,anchoring, or other surgery to accomplish the procedure, thus resultingin less trauma to the patient. Lastly, since there the procedure isaccomplished intravaginally, there is no scar or other visual evidencethat the procedure was performed.

EXAMPLE IV

The use of a number of the above described tools will now be describedas used in performing a bladder neck suspension procedure. Thisprocedure involves using one or more sutures, the suture supports, thesuture passer or the drill guide, and anchors, to suspend the bladderneck.

The patient is first prepared by installing the pubic drape 300 as wasdescribed above. Once in place, a small one inch transverse incision ismade over the pubic bone. The tip 120 of the suture passer 105 is passedthrough the rectus fascia and then sharply angled onto the abdomen sothat the point rested on the underside of the pubic periosteum. The tip120 of the suture passer 105, while maintaining contact with theunderside of the pubis, was thereafter passed distally to thepubourethral ligament and gently swept along the pubocervical fascia tothe area of the bladder neck under the guidance of a finger in thevagina. The suture passer 105 is then passed through the pubocervicalfascia and vaginal mucosa into the vagina.

A suture is then tied off to a suture support 450 on one end (if the endof the suture is not integrally molded onto the support 450 already),and the other end is then captured by a suture capturing device, such asin the suture channel 130 of the suture passer 105 as previouslydescribed. The suture is then withdrawn upward through the rectus fasciaand out through the incision. In this manner, the suture is easilypassed through the tissue of the patient with exact placement. Thesuture should be pulled slightly taut. At this time the suture support450 will be pulled against the vaginal wall.

A Mitek anchor is then used to fix the suture to the bone. This isaccomplished by one of the methods described above for placing theanchors.

EXAMPLE V

The procedure similar to that in Example IV is performed, except thatthe procedure is accomplished through the use of the "C" clamp typedrill guide, the suture support, and a plug or anchor. In thisprocedure, the "C" clamp type drill guide 600 is positioned as describedabove. The "C" clamp 600 is again used to site a pathway from the pubicarea to the vagina. A drill bit is passed through the bore 624 of the"C" clamp 600, penetrating the pubic bone and passing into the vagina. Asuture pre-tied to a suture support 450, as described above, is passedthrough the passageway created up through the wound to the abdomensurface. The suture is again supported against the vaginal wall by oneof the suture supports 450 described above.

The free end of the suture may then be tied off to secure it at theproper length by tying a knot in the suture sufficiently large toprevent it from pulling back through the hole, or by securing it to aplug. The plug may be used to secure the suture, the plug having theadded advantage that the suture tension may then be adjustable. The plugmay be a short shaft or tube member which is nearly the same size as thehole drilled. Once the suture is pulled through the bone, the plug maybe inserted into the hole, pressing the suture between the bone and theplug, thus securing it tightly. If the plug does not securely stationthe suture, the suture may be wound around the plug one or more timesand tied off in order to aid in securing the suture. If the plug istubular, the suture is knotted at the proper length and any excesssuture may be stored in the hollow area so that the suture length may beadjusted at a future date.

More than one suture may be used in conjunction with the above devices,as is believed apparent to one skilled in the art given the abovedisclosure.

Although this invention has been described in terms of certain preferredembodiments, other embodiments that are apparent to those of ordinaryskill in the art in view of the foregoing are also within the scope ofthis invention. Accordingly, the scope of the invention is intended tobe defined only by reference to the appended claims.

REFERENCES

¹ Pereyra, A. J.: A simplified surgical procedure for the correction ofstress incontinence in women. West. J. Surg., 67:223, 1959.

² Stamey, T. A.: Endoscopic Suspension of the vesical neck for urinaryincontinence in females: Report on 203 consecutive patients. Ann. Surg.,192:465, 1980.

³ Raz, S.: Modified bladder neck suspension for female stressincontinence. Urology, 17:82, 1981.

⁴ Leach, G. E.: Bone fixation technique for transvaginal needlesuspension. Urology, 31:388, 1988.

⁵ Gittes, R. F. and Loughlin, K. R.: No-incision pubovaginal suspensionfor stress incontinence. J. Urol. 138:568, 1987.

⁶ Winter, C. C.: Peripubic urethropexy for urinary stress incontinencein women. Urology, 20:408, 1982.

⁷ McKiel, C. F., Jr., Graf, E. C. and Callahan, D. H.:Marshall-Marchetti procedure: modification. J. Urol., 96:737, 1966.

⁸ Hancock, R., Brandstetter, L. H. and Hodgins, T. E.:

Transpubic suspension of the bladder neck for urinary incontinence. J.Urol., 123:667, 1980.

⁹ Richmond, J. C., Donaldson, W. R., Fu, F. and Harner, C. D.:Modification of the Bankart reconstruction with a suture anchor: reportof a new technique. Am. J. Sports Med., 19:343, 1991.

¹⁰ Pederson, B., Tesoro, D., Wertheimer, S. J. and Coraci, M.: Mitekanchor system: a new technique for tenodesis and ligamentous repair ofthe foot and ankle. J. Foot Surg., 30:48, 1991.

¹¹ Spencer, J. R., O'Conor, V. J. and Schaeffer, A. J.: A comparison ofendoscopic suspension of the vesical neck with suprapubicvesicourethropexy for treatment of stress urinary incontinence. J.Urol., 137:411, 1987.

¹² Araki, T., Takamoto, H., Hara, T. Jujimoto, H., Yoshida, M. andKatayama, Y.: The loop loosening procedure for urination difficultiesafter Stamey suspension of the vesical neck. J. Urol., 144: 1990.

¹³ Webster, G. D. and Kreder, K. J.: Voiding dysfunction followingcystourethropexy: Its evaluation and management. J. Urol., 144:1990.

I claim:
 1. A method of suspending a first tissue mass from a secondtissue mass with a preselected tension, comprising the stepsof:providing a suture, said suture having at least a first portion, asecond portion, and a third portion, the first portion of said suturebeing between the second and third portions of said suture; positioningthe first portion of said suture around the first tissue mass; securingat least one of the second and third portions of said suture to thesecond tissue mass; positioning a suture tensioner having a preselectedcross-sectional area between said suture and either of the first orsecond tissue masses; tying the second and third portions of saidsuture; and thereafterremoving the suture tensioner to produce an amountof slack in said suture corresponding to the cross-sectional area of thesuture tensioner.
 2. The method of claim 1, wherein said positioning thefirst portion of said suture step comprises positioning said suturearound a bladder neck.
 3. The method of claim 1, wherein said securingstep comprises securing said suture to a pubic bone.
 4. The method ofclaim 3, wherein said securing step comprises securing said suture in ananchor and positioning the anchor in the pubic bone.
 5. A method ofsuspending a tissue mass with a preselected tension, comprising thesteps of:securing at least one suture to a bone such that a first andsecond suture ends extend therefrom; advancing at least one of saidfirst and second ends of the suture around the tissue mass; positioninga suture tensioner having a preselected cross-sectional area between thesuture and the bone; tying said first and second suture ends; andthereafterremoving the suture tensioner to produce an amount of slack inthe suture corresponding to the cross-sectional area of the suturetensioner.
 6. The method of claim 5, wherein said advancing stepcomprises advancing at least one of said first and second ends of thesuture around a bladder neck.
 7. The method of claim 5, therein saidsecuring step comprises securing said suture to an anchor andpositioning the anchor in the bone.
 8. The method of claim 7, whereinthe step of positioning a suture tensioner comprises positioning thesuture tensioner between the suture and a pubic bone, wherein the sutureis secured to an anchor positioned in the pubic bone.
 9. A method ofsuspending a bladder neck with a preselected tension, comprising thesteps of:providing a first suture, said suture having at least a firstportion, a second portion, and a third portion, the first portion ofsaid suture being between the second and third portions of said suture;securing the first portion of said suture to tissue generally adjacentthe bladder neck; securing at least one of the second and third portionsof said suture to a first anchor; positioning the anchor in a bone;positioning a suture tensioner having a preselected cross-sectional areabetween the suture and either the bone or the tissue generally adjacentthe bladder neck; tying the second and third portions of said suture;and thereafterremoving the suture tensioner to produce an amount ofslack in said suture corresponding to the cross-sectional area of thesuture tensioner.
 10. The method of claim 9, further comprisingrepeating each of the steps of claim 9 on a second side of the bladderneck using a second suture and a second anchor to form a bladder necksuspension sling with a preselected tension.
 11. The method of claim 9,wherein the step of positioning a suture tensioner comprises positioningthe suture tensioner between the suture and the bone.
 12. The method ofclaim 9, wherein said suture is secured to the anchor before the anchoris positioned in the bone.
 13. The method of claim 9, wherein saidsuture is secured to tissue generally adjacent to the bladder neckbefore said suture is secured to the anchor.
 14. The method of claim 9,wherein said suture is secured to tissue generally adjacent to thebladder neck before the anchor is positioned in the bone.
 15. The methodof claim 9, wherein the step of positioning the anchor in a bone isaccomplished without exposing the bone by way of an open surgicalprocedure.
 16. The method of claim 15, wherein the step of positioningthe anchor in a bone is accomplished percutaneously.
 17. The method ofclaim 9, wherein the step of positioning the anchor in a bone comprisespositioning the anchor in a pubic bone.
 18. The method of claim 17,wherein the step of positioning the anchor in a bone comprisespositioning the anchor in a generally anterior surface of the pubicbone.
 19. The method of claim 18, wherein the step of positioning theanchor in a bone comprises positioning the anchor in a superior portionof the generally anterior surface of the pubic bone.
 20. The method ofclaim 18, wherein the step of positioning the anchor in a bone comprisespositioning the anchor in the pubic bone approximately 2 centimeterslateral to a symphysis pubis.
 21. The method of claim 20, wherein thestep of positioning the anchor in a bone comprises positioning theanchor in a pubic tubercle.
 22. The method of claim 9, wherein the stepof positioning the anchor in a bone is accomplished without exposing thebone.